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Lung Volume Preservation During Extubation

Primary Purpose

Weaning Failure, Pulmonary Collapse

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Lung volume preservation
Sponsored by
Althaia Xarxa Assistencial Universitària de Manresa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weaning Failure focused on measuring Weaning from Mechanical Ventilation, Reintubation, Lung Ultrasound Score, Diaphragm and intercostal thickness and thickening fraction

Eligibility Criteria

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

Inclusion Criteria:

  • Patients> 18 years who meet weaning criteria (see below)
  • More than 24 hours of mechanical ventilation (MV)
  • Signed Informed Consent by a substitute decision maker (SDM).

Weaning Criteria:

  • Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) < -15 cmH2O).
  • Absence of excessive secretions (<3 aspirations in the last 8 hours).
  • Resolution or improvement of the pathology that led to intubation.
  • Clinical stability (Heart Rate (HR) <140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses).
  • Adequate oxygenation (SatO2> 90% with Inspiratory Fraction of oxygen (FiO2) <0.4).
  • Adequate ventilatory mechanics (Respiratory rate (RR) <35 rpm, Tidal Volume (TV) > 5 ml / kg, RR / TV <100 rpm/l).
  • Confident awareness level (Glasgow Coma Scale (GCS)> 13).

Exclusion Criteria:

  • tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation.

Sites / Locations

  • Althaia Xarxa AssistencialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Lung Volume Preservation

Arm Description

SBT: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning. Patients included in the ultrasound nested study: Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. Modified LUS at the beginning of the SBT, at the end of the SBT and after extubation if successful SBT.

SBT: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning and connected to the ventilator with PEEP 5 cmH2O. Patients included in the ultrasound part: Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. Modified LUS at the beginning of the SBT, at the end of SBT and after extubation if successful SBT.

Outcomes

Primary Outcome Measures

Rate of Successful extubation
Number of patients free of mechanical ventilation
Modified Lung Ultrasound Score (LUSm) at the end of the SBT and after extubation.
Ultrasound exploration of anterior-superior, anterior-inferior, lateral and posterior-basal lateral areas of each lung. Score of each area ranges from 0 (total aeration) to 3 (total collapse). Total LUSm ranges from 0 to 24.

Secondary Outcome Measures

Rate of Reintubation
Number of patients who need reintubation after successful SBT
Rate of ICU Mortality
Patient's Mortality during ICU stay
Rate of Hospital Mortality
Patient's Mortality during hospital stay
Rate of Long term survival
Number of patients alive at 90 days after randomization
ICU length of stay
Mean of days in the ICU
Hospital length of stay
Mean of days in the hospital
Number of patients with tracheostomy
Patients who need tracheostomy
Logistic regression for successful extubation
By using a multilogistic regression, the variables related to successful extubation will be identified.
Diaphragm and intercostal thickness and thickening fraction at the beginning and at the end of the SBT.
Maximal thickness measured in M-mode in millimeters. Thickening fraction= (maximal thickness - minimal thickness)/minimal thickness (%)

Full Information

First Posted
August 29, 2022
Last Updated
August 2, 2023
Sponsor
Althaia Xarxa Assistencial Universitària de Manresa
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1. Study Identification

Unique Protocol Identification Number
NCT05526053
Brief Title
Lung Volume Preservation During Extubation
Official Title
Preserving Lung Volume During Weaning and Extubation. A Prospective, Multicenter Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Althaia Xarxa Assistencial Universitària de Manresa

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
Introduction: At present, the best spontaneous breathing trial (SBT) during weaning from mechanical ventilation is a 30-min test with pressure support (PSV) 8 cmH2O without positive end-expiratory pressure (PEEP). There is a debate about the possible collapse of some alveolar units during such SBT and during extubation with continuous suctioning. A few experiences show extubation without suctioning as feasible and safe. Lung ultrasound is a non invasive and useful exploration tool to assess the lung aeration. Hypothesis: Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. The preserved lung volume of each SBT and extubation strategy can be assessed by using lung ultrasound. Primary objective: To define the rates of successful extubation in two extubation approaches aiming at different levels of lung volume preservation: standard SBT (30-min PSV 8 cmH2O without PEEP followed by extubation with continuous suctioning) versus experimental SBT (PSV8+ PEEP 5 cmH2O followed by extubation without suctioning). To define the lung aeration levels using the modified Lung Ultrasound Score (LUS) of each SBT strategy. Secondary objectives: Reintubation rate, ICU and hospital stays, and mortality in each group. To define the diaphragm and intercostal thickness and thickening fraction in different levels of lung volume preservation. Design: Prospective, multicenter, randomized study. Two opposing extubation strategies are compared in randomly assigned patients.The level of aeration is assessed using lung ultrasound.
Detailed Description
HYPOTHESIS Techniques aimed at preserving lung volume during SBT and extubation can yield higher rates of successful extubation. Lung Ultrasound Score (LUS) might be lower in techniques aiming to preserve lung volume suggesting less lung collapse. METHODS Patients with inclusion criteria and none exclusion criteria will be randomized to the follow strategies: Standard: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning. Lung volume preservation: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning. The randomization will be done with the built-in tool of the RedCap® Platform with computerized random number tables and blocks of n patients for each hospital. The investigators of each center will have a profile and a password to log into the RedCap and proceed with randomization of each patient. The investigator of each center will have access only to the data and randomization of his/her center. In extubation failure patients (those who does not tolerate the SBT or not extubated), the attending physician will decide on the treatment, either support with non-invasive ventilation or with high flow nasal cannula, or reintubation. Patients who present extubation failure will not be randomized in later SBTs. During the SBT, interventions that the physician considers necessary to monitor the success of the test, such as echocardiography or thoracic ultrasound, may be performed. In the event that the physician considers that the findings of these tests do not guarantee successful extubation despite fulfillment of extubation criteria according to the study protocol, the attending physician's decision will prevail over the study protocol. In these cases, it will be recorded in the case report form (CRF) as extubation failure due to "other causes of weaning failure". Not all patients and participating centers will collect data from the lung, diaphragm and intercostal ultrasound assessment. Only those patients that showed interest and proved ultrasound skills, will participate in the ultrasound part of the nested study. Those patients included in the Ultrasound assessment part, an ultrasonographic exploration will be performed at different times of the SBT and extubation: before starting the SBT, at the final of the SBT and after extubation. To proof the hypothesis related to the LUS and considering a minimum difference of 1 point (LUSm ranges from 0 to 24 points), we anticipate that 93 in each arm are required . OBJECTIVES: Primary: To determine the rate of successful extubation in two opposite weaning strategies. To determine the LUS in two opposite weaning strategies. Secondary: To determine the ICU stay, hospital stay, hospital survival, and 90-day survival in the two groups. To identify the causes of extubation failure (clinical and ultrasonographic). To determine the diaphragm and intercostal thickness and thickening fraction in the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weaning Failure, Pulmonary Collapse
Keywords
Weaning from Mechanical Ventilation, Reintubation, Lung Ultrasound Score, Diaphragm and intercostal thickness and thickening fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be allocated to one of the two strategies: Standard OR Preserving Lung volume
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1644 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
SBT: PSV 8 cmH2O, PEEP 0 cmH2O for 30 minutes and, when successful, followed by extubation with continuous suctioning. Patients included in the ultrasound nested study: Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. Modified LUS at the beginning of the SBT, at the end of the SBT and after extubation if successful SBT.
Arm Title
Lung Volume Preservation
Arm Type
Experimental
Arm Description
SBT: PSV 8 cmH2O, PEEP 5 cmH2O for 30 minutes and, when successful, followed by direct extubation without suctioning and connected to the ventilator with PEEP 5 cmH2O. Patients included in the ultrasound part: Diaphragm and intercostal thickness and thickening fraction at the beginning and the end of the SBT. Modified LUS at the beginning of the SBT, at the end of SBT and after extubation if successful SBT.
Intervention Type
Other
Intervention Name(s)
Lung volume preservation
Intervention Description
Extubate the patient connected to the ventilator and PEEP of 5 cmH2O after a successful SBT also using PEEP.
Primary Outcome Measure Information:
Title
Rate of Successful extubation
Description
Number of patients free of mechanical ventilation
Time Frame
72 hours
Title
Modified Lung Ultrasound Score (LUSm) at the end of the SBT and after extubation.
Description
Ultrasound exploration of anterior-superior, anterior-inferior, lateral and posterior-basal lateral areas of each lung. Score of each area ranges from 0 (total aeration) to 3 (total collapse). Total LUSm ranges from 0 to 24.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Rate of Reintubation
Description
Number of patients who need reintubation after successful SBT
Time Frame
72 hours
Title
Rate of ICU Mortality
Description
Patient's Mortality during ICU stay
Time Frame
90 days
Title
Rate of Hospital Mortality
Description
Patient's Mortality during hospital stay
Time Frame
90 days
Title
Rate of Long term survival
Description
Number of patients alive at 90 days after randomization
Time Frame
90 days
Title
ICU length of stay
Description
Mean of days in the ICU
Time Frame
90 days
Title
Hospital length of stay
Description
Mean of days in the hospital
Time Frame
90 days
Title
Number of patients with tracheostomy
Description
Patients who need tracheostomy
Time Frame
90 days
Title
Logistic regression for successful extubation
Description
By using a multilogistic regression, the variables related to successful extubation will be identified.
Time Frame
90 days
Title
Diaphragm and intercostal thickness and thickening fraction at the beginning and at the end of the SBT.
Description
Maximal thickness measured in M-mode in millimeters. Thickening fraction= (maximal thickness - minimal thickness)/minimal thickness (%)
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients> 18 years who meet weaning criteria (see below) More than 24 hours of mechanical ventilation (MV) Signed Informed Consent by a substitute decision maker (SDM). Weaning Criteria: Suitable cough (Ability to raise secretions to the endotracheal tube) (or Maximal inspiratory pressure (MIP) < -15 cmH2O). Absence of excessive secretions (<3 aspirations in the last 8 hours). Resolution or improvement of the pathology that led to intubation. Clinical stability (Heart Rate (HR) <140 bpm, Systolic Blood Pressure (SBP) 90-160, without vasopressors or at minimum doses). Adequate oxygenation (SatO2> 90% with Inspiratory Fraction of oxygen (FiO2) <0.4). Adequate ventilatory mechanics (Respiratory rate (RR) <35 rpm, Tidal Volume (TV) > 5 ml / kg, RR / TV <100 rpm/l). Confident awareness level (Glasgow Coma Scale (GCS)> 13). Exclusion Criteria: tracheostomy, do-not-reintubate orders, decision of the responsible physician (e.g., due to a preference for a particular weaning technique according to the underlying pathology), absence of informed consent, mental incapacity without legal representation. For ultrasound assessment: skilled explorer not present at the time of the SBT, inadequate ultrasound window. Known diaphragmatic paralysis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos Subira, PhD
Phone
+346479392053
Email
carlessubira@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Fernandez, PhD
Organizational Affiliation
Althaia Xarxa Assistencial de Manresa
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos Subira, PhD
Organizational Affiliation
Althaia Xarxa Assitencial de Manresa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Althaia Xarxa Assistencial
City
Manresa
State/Province
Bacelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carles Subira
Phone
+34637423355
Email
csubira@althaia.cat

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If any researcher is interested on exploratory analysis, it should be presented to the principal investigator to get the approval for it.
Citations:
PubMed Identifier
7921460
Citation
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Lung Volume Preservation During Extubation

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