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NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases (NIVATS-2)

Primary Purpose

Lung Diseases, Interstitial

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy
Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases, Interstitial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient with purported interstitial lung disease Patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment Minimum age: 18 years Exclusion Criteria: Contra-indication for surgery Uncontrolled oesophageal gastric reflux despite optimal treatment Thoracic deformation (For example, pectus excavatum/carinatum or major scoliosis) Risk of pleural adhesion (For example, patient who has already undergone thoracic surgery) History of abnormal bleeding Predictable risk of difficult intubation Body mass index (BMI) > 30 Severe cardiovascular comorbidity (For example, instable ischemic cardiomyopathy) Unable to comply with all trial procedures/visits (For example, language barriers, upcoming move of household to another region, unwillingness to schedule the required followup visits.) Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent.) Potential interference from another study (The patient is participating in another interventional study, or has done so in the past month, or is affected by an exclusion period stipulated by a previous study.) Non-beneficiary of the French single-payer national medical insurance system Lack of signed informed consent

Sites / Locations

  • Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de VilleneuveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NIVATS

IGAVATS

Arm Description

Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS).

Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS).

Outcomes

Primary Outcome Measures

The level of diagnostic confidence based on centralized histology only
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.

Secondary Outcome Measures

The level of diagnostic confidence based on routine histology only
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Classification according to ATS/ERS at MDA-1
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Classification according to ATS/ERS at MDA-2
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Inter-histologist concordance for ATS/ERS categories
Inter-histologist concordance for ATS/ERS categories
Longest length (mm) of biopsy specimens
Longest length (mm) of biopsy specimens
Volume (cc) of biopsy specimens
Volume (cc) of biopsy specimens
Weight (g) of biopsy specimens
Weight (g) of biopsy specimens
Numerical scale for biopsy quality
The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).
Preparation time (minutes)
Minutes lapsed between entering the surgical ward and entering the operating room (OR)
OR time (minutes)
Minutes lapsed between entering and exiting the OR
Recovery room (RR) time (minutes)
Minutes lapsed between exiting the OR and exiting the surgical ward.
Post-RR time (hours)
Hours lapsed between exit from surgical ward, and discharge from hospital
First drink time (minutes)
Minutes lapsed between application of last bandage on surgical wounds to first drink
Post-operative fasting time (hours)
Hours lapsed between application of last bandage on surgical wounds to first meal
Time with chest tube in place (hours)
Hours lapsed between application of last bandage on surgical wounds to removal of chest tube
Visual analogue scale score for post-operative pain
The patient will be asked to evaluate his/her level of post-operative pain using a numeric rating scale (0-10) the morning after surgery where 0 represents no pain, and 10 represents the worse possible pain.
Patient satisfaction (satisfied vs unsatisfied)
The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)
Time to dischargeability
Dischargeability is defined as meeting the following criteria: (i) satisfactory pain control via oral analgesia; (ii) ability to mobilize and return to usual autonomy; (iii) absence of clinical, laboratory and radiological complications; (iv) stable respiratory state compatible pre-surgical state and home discharge; (v) vital signs are normal for the patient; (vi) chest tube removal >12 hours.
Length of initial hospitalization stay (hours)
Length of initial hospitalization stay (hours)
Cumulative days of hospitalization
Cumulative days of hospitalization
Cumulative days of exacerbation
Cumulative days of exacerbation
Days alive, not exacerbating and not in hospital
Days alive, not exacerbating and not in hospital
Forced vital capacity (litres)
Forced vital capacity (litres)
Forced vital capacity (litres)
Forced vital capacity (litres)
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Forced vital capacity (% theoretical value)
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Presence / absence of complications
Complications will be listed and classified (Minor: (1) Any complication without need for pharmacologic treatment or other intervention; (2) Any complication that requires pharmacologic treatment or minor intervention only; Major: (3) Any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy; (3a) Intervention does not require general anesthesia; (3b) Intervention requires general anesthesia; (4) Any complication requiring intensive care unit management and life support; (4a) Single organ dysfunction; (4b) Multiorgan dysfunction; (5) Any complication leading to the death of the patient.

Full Information

First Posted
January 18, 2023
Last Updated
August 18, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)
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1. Study Identification

Unique Protocol Identification Number
NCT05722340
Brief Title
NIVATS Versus IGAVATS: a Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
Acronym
NIVATS-2
Official Title
Video-assisted Thoracic Surgery for Lung Biopsy Using Non-intubated (NIVATS) Versus Intubated General Anaesthesia (IGAVATS): a Randomized, Controlled, Pilot Trial Addressing Biopsy Quality in Undetermined Interstitial Lung Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2023 (Actual)
Primary Completion Date
November 24, 2025 (Anticipated)
Study Completion Date
November 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Grace Asso (Groupe francophone de Réhabilitation Améliorée après Chirurgie)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ILD) in terms of diagnostic confidence as determined by histologists.
Detailed Description
The primary objective of this study is to compare two independent groups of patients requiring lung biopsy for undetermined interstitial lung disease (ILD) in terms of diagnostic confidence as determined by histologists. The experimental arm will be operated under a neoteric non-intubated video assisted thoracic surgery (NIVATS) technique and the comparator arm under a usual intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) technique. Secondarily, the two groups will also be compared in terms of: (i) further variables associated with histology, biopsy quality and size; (ii) surgical performance, (iii) patient trajectories and lung function; (iv) quality of life, and (v) harms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this prospective, parallel group, randomized (1:1), controlled, pilot trial, screening will take place during routine multidisciplinary assessment (MDA) meetings. The study is then presented to eligible patients during their next pre-surgical visits; if the patients are interested in participating, informed consent procedures are completed (again during routine visits) and the patients are randomized to two arms. In the experimental arm, patients will undergo NIVATS for lung biopsy, and in the standard arm, patients will undergo traditional IGAVATS for lung biopsy. Histology is then performed as usual, before entering a centralized pathway for a second analysis by an expert external to the study, and a second routine MDA convened (both blinded to study arms). Patients are followed-up for 12 months.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
To assure the blinding of non-surgical study staff (MDA participants, histologists, etc), allocation results in the electronic case report (eCRF) form are made available to designated surgical staff only. Patients, investigators / outcome assessors / care givers and study staff are blinded to allocation results in as much as possible. Only designated surgical staff (identified prior to centre initiation and kept to a strict necessary minimum) not otherwise involved in outcome assessment or patient care have access to allocation results on the eCRF and are summoned to maintain secrecy. Data analysts will not be involved in trial field logistics and will be blinded. During analyses, when group assignments are first required, they will only be revealed as "group A" or "group B". Only when analyses have been completed will the exact nature of groups be revealed.
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIVATS
Arm Type
Experimental
Arm Description
Lung biopsy is performed using non-intubated video-assisted thoracic surgery (NIVATS).
Arm Title
IGAVATS
Arm Type
Active Comparator
Arm Description
Lung biopsy is performed using Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS).
Intervention Type
Procedure
Intervention Name(s)
Non-intubated video-assisted thoracic surgery (NIVATS) for lung biopsy
Intervention Description
An epidural anaesthesia associated with mild sedation requiring no ventilation is used.
Intervention Type
Procedure
Intervention Name(s)
Intubated general anaesthesia video-assisted thoracic surgery (IGAVATS) for lung biopsy
Intervention Description
Uses a traditional deep anaesthesia and one-lung ventilation
Primary Outcome Measure Information:
Title
The level of diagnostic confidence based on centralized histology only
Description
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Time Frame
Day 1 to day 15
Secondary Outcome Measure Information:
Title
The level of diagnostic confidence based on routine histology only
Description
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Time Frame
Day 1 to day 15
Title
The level of diagnostic confidence achieved at multidisciplinary assessment (MDA)-2
Description
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Time Frame
Day 7 to day 28
Title
Change in the level of diagnostic confidence for the most favoured diagnosis between multidisciplinary assessment (MDA)-1 and multidisciplinary assessment (MDA)-2
Description
The level of diagnostic confidence for a given diagnosis is established according to a quantitative scale ranging from '0' (absolute rule-out) to '10' (diagnostic certainty). A visual guide for scale use is provided with scores <1 corresponding to "alternate diagnosis", scores >=1 and <4 corresponding to "indeterminate", scores >=4 and <7 corresponding to "probable", and scores >=7 corresponding to "highly probable" categories.
Time Frame
Day 7 to day 28
Title
Classification according to ATS/ERS at MDA-1
Description
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Time Frame
Day -28 to day -3
Title
Classification according to ATS/ERS at MDA-2
Description
Classification according to the American Thoracic Society / European Respiratory society: Alternative diagnosis / Indeterminate / Probable / Highly probable
Time Frame
Day 7 to day 28
Title
Inter-histologist concordance for ATS/ERS categories
Description
Inter-histologist concordance for ATS/ERS categories
Time Frame
Day 1 to 15
Title
Longest length (mm) of biopsy specimens
Description
Longest length (mm) of biopsy specimens
Time Frame
Day 1 to 15
Title
Volume (cc) of biopsy specimens
Description
Volume (cc) of biopsy specimens
Time Frame
Day 1 to 15
Title
Weight (g) of biopsy specimens
Description
Weight (g) of biopsy specimens
Time Frame
Day 1 to 15
Title
Numerical scale for biopsy quality
Description
The histologist ranks biopsy quality from worst imaginable (0) to excellent (10).
Time Frame
Day 1 to 15
Title
Preparation time (minutes)
Description
Minutes lapsed between entering the surgical ward and entering the operating room (OR)
Time Frame
Day 0
Title
OR time (minutes)
Description
Minutes lapsed between entering and exiting the OR
Time Frame
Day 0
Title
Recovery room (RR) time (minutes)
Description
Minutes lapsed between exiting the OR and exiting the surgical ward.
Time Frame
Day 0
Title
Post-RR time (hours)
Description
Hours lapsed between exit from surgical ward, and discharge from hospital
Time Frame
Day 1 to 15
Title
First drink time (minutes)
Description
Minutes lapsed between application of last bandage on surgical wounds to first drink
Time Frame
Day 0
Title
Post-operative fasting time (hours)
Description
Hours lapsed between application of last bandage on surgical wounds to first meal
Time Frame
Day 0
Title
Time with chest tube in place (hours)
Description
Hours lapsed between application of last bandage on surgical wounds to removal of chest tube
Time Frame
Day 0
Title
Visual analogue scale score for post-operative pain
Description
The patient will be asked to evaluate his/her level of post-operative pain using a numeric rating scale (0-10) the morning after surgery where 0 represents no pain, and 10 represents the worse possible pain.
Time Frame
Day 1, morning after surgery
Title
Patient satisfaction (satisfied vs unsatisfied)
Description
The patient will be asked to evaluate his/her satisfaction (satisfied vs unsatisfied)
Time Frame
Hospital discharge (expected maximum of 15 days)
Title
Time to dischargeability
Description
Dischargeability is defined as meeting the following criteria: (i) satisfactory pain control via oral analgesia; (ii) ability to mobilize and return to usual autonomy; (iii) absence of clinical, laboratory and radiological complications; (iv) stable respiratory state compatible pre-surgical state and home discharge; (v) vital signs are normal for the patient; (vi) chest tube removal >12 hours.
Time Frame
Days 1 to 15
Title
Length of initial hospitalization stay (hours)
Description
Length of initial hospitalization stay (hours)
Time Frame
Expected maximum of 15 days
Title
Cumulative days of hospitalization
Description
Cumulative days of hospitalization
Time Frame
12 months
Title
Cumulative days of exacerbation
Description
Cumulative days of exacerbation
Time Frame
12 months
Title
Days alive, not exacerbating and not in hospital
Description
Days alive, not exacerbating and not in hospital
Time Frame
12 months
Title
Forced vital capacity (litres)
Description
Forced vital capacity (litres)
Time Frame
Day -28 to Day -1
Title
Forced vital capacity (litres)
Description
Forced vital capacity (litres)
Time Frame
12 months
Title
Forced vital capacity (% theoretical value)
Description
Forced vital capacity (% theoretical value)
Time Frame
Day -28 to Day -1
Title
Forced vital capacity (% theoretical value)
Description
Forced vital capacity (% theoretical value)
Time Frame
12 months
Title
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
Day -28 to Day -1
Title
Euroqol 5 dimensions 5 levels questionnaire: mobility dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
12 months
Title
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
Day -28 to Day -1
Title
Euroqol 5 dimensions 5 levels questionnaire: self-care dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
12 months
Title
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
Day -28 to Day -1
Title
Euroqol 5 dimensions 5 levels questionnaire: usual activities dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
12 months
Title
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
Day -28 to Day -1
Title
Euroqol 5 dimensions 5 levels questionnaire: pain/discomfort dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
12 months
Title
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
Day -28 to Day -1
Title
Euroqol 5 dimensions 5 levels questionnaire: anxiety/depression dimension score
Description
In its original version, this self-administered questionnaire consists of two pages: the first contains the EQ-5D descriptive system and the second a visual analogue scale. The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). The respondent must indicate one intensity level for each dimension.
Time Frame
12 months
Title
Presence / absence of complications
Description
Complications will be listed and classified (Minor: (1) Any complication without need for pharmacologic treatment or other intervention; (2) Any complication that requires pharmacologic treatment or minor intervention only; Major: (3) Any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy; (3a) Intervention does not require general anesthesia; (3b) Intervention requires general anesthesia; (4) Any complication requiring intensive care unit management and life support; (4a) Single organ dysfunction; (4b) Multiorgan dysfunction; (5) Any complication leading to the death of the patient.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with purported interstitial lung disease Patient requiring a surgical lung biopsy to reinforce diagnosis according to current recommendations and validated by a multidisciplinary assessment Minimum age: 18 years Exclusion Criteria: Contra-indication for surgery Uncontrolled oesophageal gastric reflux despite optimal treatment Thoracic deformation (For example, pectus excavatum/carinatum or major scoliosis) Risk of pleural adhesion (For example, patient who has already undergone thoracic surgery) History of abnormal bleeding Predictable risk of difficult intubation Body mass index (BMI) > 30 Severe cardiovascular comorbidity (For example, instable ischemic cardiomyopathy) Unable to comply with all trial procedures/visits (For example, language barriers, upcoming move of household to another region, unwillingness to schedule the required followup visits.) Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent.) Potential interference from another study (The patient is participating in another interventional study, or has done so in the past month, or is affected by an exclusion period stipulated by a previous study.) Non-beneficiary of the French single-payer national medical insurance system Lack of signed informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothée JOUITTEAU, Doctor
Phone
003467335958
Email
t-jouitteau@chu-montpellier.fr
Facility Information:
Facility Name
Département d'Anesthésie et Réanimation Cardiothoracique - CHU Arnaud de Villeneuve
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothée JOUITTEAU, Doctor
Phone
003467335958
Email
t-jouitteau@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data will be made available to persons who address a reasonable request to the study director. Individual participant data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. The study protocol, participant Information materials, worksheet and data sharing plan will also be made available to the public.
IPD Sharing Time Frame
Datasets that underlie the results reported in the article (text, tables, figures, and appendices) can be requested after the publication process has been completed. The study protocol will be published in an open-access, peer-reviewed journal. Other key documents will be made available on the Open Science Framework as they are finalized.
IPD Sharing Access Criteria
The conditions under which members of the public will be granted access to datasets are: The data will be used/examined in a not-for-profit manner; The data will not be used in an attempt to identify a participant or group of participants; The user does not work for a private insurance company; The data will not be used in support of any kind of private insurance policy or health penalties; The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; The user will state why they wish to access the data. If the data do not fulfil the requirements of the reference methodology (MR-00X) (ex: data about religion, etc.), the appropriate CNIL approval has to be obtained by the user. If the data will be used outside the European Union, standard contractual clauses have to be signed between Montpellier University Hospital and the user before sharing data.
IPD Sharing URL
https://osf.io/dnbfg/

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