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Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD) (Eval 3V-BPCO)

Primary Purpose

COPD

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electrical impedance tomography (EIT)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD focused on measuring Chronic obstructive pulmonary disease, non invasive ventilation, end-expiratory lung volume, electrical impedance tomography

Eligibility Criteria

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

Inclusion Criteria: Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital; Patient benefiting from social protection from the national health insurance fund; Patient having read the patient information letter and given his non-objection to participate in the study. Exclusion Criteria: Obesity with a BMI > 35; Respiratory exacerbation during treatment; Patient with one or more contraindications to the implementation of EIT(7): Pacemaker, defibrillator, electric active medical device; Damaged skin condition, dressing on the observation area; Risk related to fitting the belt (fracture, spinal lesions, etc.); Uncontrollable movements; Current electrotherapy; Presence of a magnetic field (magnetic resonance imaging); Other bioimpedance measurements in progress; Pregnant woman ; Tidal volume < 1ml/kg; Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3); Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision; Patient included in other protocols that may interact with this study;

Sites / Locations

  • Hôpital Haut Lévêque, Centre Hospitalier Universitaire de BordeauxRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with COPD

Arm Description

Patients with COPD in stable condition fitted with long-term NIV

Outcomes

Primary Outcome Measures

End-Expiratory Lung Impedance (EELI) evolution during NIV sessions
End-Expiratory Lung impedance is related to the End-Expiratory Lung Volume reflecting the functional residual capacity (FRC). It is obtained by electrical impedance tomography. EELI values are presented in arbitrary values (v.a) and can vary greatly between individuals. Thus, as previously proposed by (4), the EELI values during the different measurement phases will be assessed and presented as a percentage change from their reference value. The main objective of this study aims to observe the evolution of the EELI under NIV in stable COPD patients, the reference EELI value will be that measured at T1 (NIV initiation+1 minute), compared to that measured at T2 (NIV+20minutes) under the ∆EELI%T2 abbreviation from the following calculation: ∆EELI%T2 = (EELIT1-EELIT2)/EELIT1*100

Secondary Outcome Measures

End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions
A secondary objective of this research is to observe the evolution of the EELI before, during and after the NIV. In this context, the reference value will be the measurement of the EELI before the NIV, i.e. EELIT0. Thus the EELI values at T1 (NIV initiation+1 minute), T2 (NIV+20minutes) and T3 (5minutes after NIV) will be presented as a percentage change compared to T0 and will be respectively ∆EELI%T1, ∆EELI %T2 and ∆EELI%T3, respecting the following calculation: ∆EELI%Tx = (EELIT0-EELITx)/EELIT0*100.
Transcutaneous capnia
A secondary objective of this research is to observe the evolution of transcutaneous capnia (PtCO2) in mmHg via a capnograph before (T0), during (T1, T2) and after NIV (T3).

Full Information

First Posted
July 11, 2023
Last Updated
July 11, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05953298
Brief Title
Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Acronym
Eval 3V-BPCO
Official Title
Evaluation by Electrical Impedancemetry of the Variation of Lung Volumes Under NIV in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

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 aim of this physiologic research is to assess lung volumes variations under NIV in stable COPD patients to understand the impact of "high-intensity" ventilation following the current recommendations. The main objective is to evaluate the variation of End-expiratory lung volume (EELV) reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography during a 20 minutes NIV session.
Detailed Description
In patients with COPD, European recommendations recommend the use of NIV with a "high pressure" setting (1). These ventilatory modalities go against what is done in acute. Indeed, in this case, the pressures are much lower, because the risk of asynchronies and dynamic hyperinflation under NIV is then very important. The usual techniques for evaluating lung volume and dynamic hyperinflation do not allow this to be measured under NIV. Assessing lung volumes under NIV in stable COPD patients is therefore of major interest in understanding the impact of "high-intensity" ventilation. Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level.(2) Among these measures, the End-Expiratory Lung Impedance (EELI), strongly correlated to the End-Expiratory Lung Volume (EELV), is the reflection of the FRC and can be dynamically monitored in real time at the patient's bedside(3). However, it has never been used in stable COPD patients on NIV, and could be an interesting tool for analyzing the impact of NIV on lung volumes. The main objective is to evaluate the variation of EELV reflecting the functional residual capacity (FRC), via the End-tidal lung impedance (EELI) obtained by electrical impedance tomography, during a 20-minute session of NIV in patients with COPD at the stable state The secondary objectives will be: To evaluate the variation of the EELV reflecting the FRC, via the EELI obtained by electrical impedance tomography, before, during and after a 20-minute session of NIV in stable-state COPD patients. Evaluate the relationship between the variation of PtCO2, and that of EELV under NIV, reflection of the FRC, via the EELI obtained by electrical impedance tomography. Identify responder and non-responder patient subgroups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Chronic obstructive pulmonary disease, non invasive ventilation, end-expiratory lung volume, electrical impedance tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with COPD
Arm Type
Experimental
Arm Description
Patients with COPD in stable condition fitted with long-term NIV
Intervention Type
Device
Intervention Name(s)
Electrical impedance tomography (EIT)
Intervention Description
Electrical impedance tomography (EIT) is a non-invasive evaluation tool, without radiation, simple to set up at the patient's bedside and validated, making it possible to monitor the distribution of ventilation and lung recruitment with high temporal resolution, dynamic way and at a regional level
Primary Outcome Measure Information:
Title
End-Expiratory Lung Impedance (EELI) evolution during NIV sessions
Description
End-Expiratory Lung impedance is related to the End-Expiratory Lung Volume reflecting the functional residual capacity (FRC). It is obtained by electrical impedance tomography. EELI values are presented in arbitrary values (v.a) and can vary greatly between individuals. Thus, as previously proposed by (4), the EELI values during the different measurement phases will be assessed and presented as a percentage change from their reference value. The main objective of this study aims to observe the evolution of the EELI under NIV in stable COPD patients, the reference EELI value will be that measured at T1 (NIV initiation+1 minute), compared to that measured at T2 (NIV+20minutes) under the ∆EELI%T2 abbreviation from the following calculation: ∆EELI%T2 = (EELIT1-EELIT2)/EELIT1*100
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
End-Expiratory Lung Impedance (EELI) evolution before, during and NIV sessions
Description
A secondary objective of this research is to observe the evolution of the EELI before, during and after the NIV. In this context, the reference value will be the measurement of the EELI before the NIV, i.e. EELIT0. Thus the EELI values at T1 (NIV initiation+1 minute), T2 (NIV+20minutes) and T3 (5minutes after NIV) will be presented as a percentage change compared to T0 and will be respectively ∆EELI%T1, ∆EELI %T2 and ∆EELI%T3, respecting the following calculation: ∆EELI%Tx = (EELIT0-EELITx)/EELIT0*100.
Time Frame
Day 1
Title
Transcutaneous capnia
Description
A secondary objective of this research is to observe the evolution of transcutaneous capnia (PtCO2) in mmHg via a capnograph before (T0), during (T1, T2) and after NIV (T3).
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with COPD in stable condition fitted with long-term NIV followed at Bordeaux University Hospital; Patient benefiting from social protection from the national health insurance fund; Patient having read the patient information letter and given his non-objection to participate in the study. Exclusion Criteria: Obesity with a BMI > 35; Respiratory exacerbation during treatment; Patient with one or more contraindications to the implementation of EIT(7): Pacemaker, defibrillator, electric active medical device; Damaged skin condition, dressing on the observation area; Risk related to fitting the belt (fracture, spinal lesions, etc.); Uncontrollable movements; Current electrotherapy; Presence of a magnetic field (magnetic resonance imaging); Other bioimpedance measurements in progress; Pregnant woman ; Tidal volume < 1ml/kg; Patient having read the patient information letter and refusing to participate in the study (Loi Jardé research category 3); Patient under guardianship, curatorship, or deprived of freedom of administrative or judicial decision; Patient included in other protocols that may interact with this study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leo GRASSION, MD
Phone
+335 57 65 63 38
Email
leo.grassion@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo GRASSION, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Haut Lévêque, Centre Hospitalier Universitaire de Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leo GRASSION, MD
Phone
+335 57 65 63 38
Email
leo.grassion@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Leo GRASSION, MD
First Name & Middle Initial & Last Name & Degree
Carole DECLOEDT
First Name & Middle Initial & Last Name & Degree
Alexandre GARCIA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28494170
Citation
Schwarz SB, Magnet FS, Windisch W. Why High-Intensity NPPV is Favourable to Low-Intensity NPPV: Clinical and Physiological Reasons. COPD. 2017 Aug;14(4):389-395. doi: 10.1080/15412555.2017.1318843. Epub 2017 May 11.
Results Reference
background
PubMed Identifier
27596161
Citation
Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
Results Reference
background
PubMed Identifier
12528020
Citation
Hinz J, Hahn G, Neumann P, Sydow M, Mohrenweiser P, Hellige G, Burchardi H. End-expiratory lung impedance change enables bedside monitoring of end-expiratory lung volume change. Intensive Care Med. 2003 Jan;29(1):37-43. doi: 10.1007/s00134-002-1555-4. Epub 2002 Nov 20.
Results Reference
background
PubMed Identifier
27997805
Citation
Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.
Results Reference
background

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Evaluation by Electrical Impedancemetry of the Variation in Lung Volumes Under Non-invasive Ventilation (NIV) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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