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Assessment of Inspiratory Muscles Strength and Endurance Evolution on Difficult to Wean Patients in Intensive Care Unit (EFES)

Primary Purpose

Weaning From Mechanical Ventilation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Difficult to wean patients
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Weaning From Mechanical Ventilation focused on measuring Ventilated induced diaphragmatic dysfunction, Weaning, Inspiratory muscle training

Eligibility Criteria

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

Inclusion Criteria:

  • Patient ventilated more than 18h in a controlled mode;
  • First single breathe trial of 2 hours failure;

  • Presence of sevrability criterias definied by the European consensus conference in 2007 as usually used:

    • diminution of the sedfative agents ;
    • Patients with spontaneous beath in VAC mode or patient ventilated in a VSAI-PEP mode;
    • PaO2/FiO2 ≥150;
    • Absence d'inotropes ou de vasopresseurs à forte dose ou dose croissante (<1mg/h);
    • SaO2 > 90% with FiO2 ≤ 50%;
    • PEP ≤ 8cmH2O;
    • Corporal température between 36°C and 39°C;
    • Glasgow Score ≥ 8;
  • Patient or family consent.

Exclusion Criteria:

  • Age < 18 years ;
  • medically unstable;
  • Poor vital pronostic at very short term;
  • Cardiac arrest with a poor neurological prognostic;
  • Neuromuscular disease ;
  • Tracheostomy ;
  • Current pregnancy ;
  • Patients with guardianship or trusteeship.

Sites / Locations

  • Hôpital Haut-Lévêque
  • Hôpital Pellegrin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Difficult to wean patients

Arm Description

Maximal Inspiratory Pressure and Peak Pressure from the inclusion day to the extubation day will be measure.

Outcomes

Primary Outcome Measures

Maximal Inspiratory Pressure score assessment
Correlation between Maximal Inspiratory Pressure score assessment (inspiratory muscle strength index) and duration of weaning period

Secondary Outcome Measures

Peak Pressure assessment
Correlation between Peak Pressure assessment (inspiratory muscle endurance index) and duration of weaning period
Maximal Inspiratory Pressure score assessment after weaning success
Correlation between Maximal Inspiratory Pressure score assessment and weaning success (not re-intubated in the 48h post-extubation)
Peak Pressure assessment after weaning success
Correlation between Peak Pressure assessment and weaning success.
Maximal Inspiratory Pressure score assessment and hospitalization
Correlation between Maximal Inspiratory Pressure score assessment and intensive care unit length
Peak Pressure assessment and hospitalization
Correlation between Peak Pressure assessment and intensive care unit length
Adverses events
Adverses events occur during Maximal Inspiratory Pressure and Peak Pressure measures

Full Information

First Posted
May 2, 2017
Last Updated
May 12, 2020
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03140267
Brief Title
Assessment of Inspiratory Muscles Strength and Endurance Evolution on Difficult to Wean Patients in Intensive Care Unit
Acronym
EFES
Official Title
Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 14, 2017 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)

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
Ventilator-induced diaphragmatic dysfunction appears to contribute to slow weaning from mechanical ventilation. Several trials of inspiratory muscle training to facilitate weaning in intensive care have been performed, with inconsistent results, utilizing different methods of IMT in different populations. To perform the best IMT program, we need to know the physio-pathology of the diaphragm in difficult to wean patients. This study proposes to discriminate the two main characteristics of the inspiratory muscles: strength and endurance. By analyzing the evolution of strength and endurance during all the weaning period, we want to know which characteristic has the more deficiency to adapt in a second time an effective program of IMT.
Detailed Description
The main objective of this study is to determinate which characteristic of inspiratory muscles between strength and endurance has more deficiency in difficult to wean patients. In a second time, the results of this study will help to choose the best IMT program to assess his impact on the weaning time. We are going to conduct an interventional trial because of Peak Pressure measure, which is not measure in care practice. Following 18h of invasive mechanical ventilation in a controlled mode, the failure of the first single breathe trial of 2 hours and the presence of sevrability criterias defined by the European consensus conference in 2007, 80 participants will be included in the medical intensive care unit of Bordeaux's hospital. We'll perform measurements of the Maximal Inspiratory Pressure and Peak Pressure from the inclusion to the extubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weaning From Mechanical Ventilation
Keywords
Ventilated induced diaphragmatic dysfunction, Weaning, Inspiratory muscle training

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Difficult to wean patients
Arm Type
Experimental
Arm Description
Maximal Inspiratory Pressure and Peak Pressure from the inclusion day to the extubation day will be measure.
Intervention Type
Diagnostic Test
Intervention Name(s)
Difficult to wean patients
Intervention Description
Subjects will be following during 18 hours in an invasive mechanical ventilation in a controlled mode. After failure of first single breath trial during 2 hours and presence of sevrability criterias defined by the European consensus conference in 2007, Maximal Inspiratory Pressure and Peak Pressure will be measure.
Primary Outcome Measure Information:
Title
Maximal Inspiratory Pressure score assessment
Description
Correlation between Maximal Inspiratory Pressure score assessment (inspiratory muscle strength index) and duration of weaning period
Time Frame
Daily measure (from inclusion day (day 1) to extubation day (maximum day 28))
Secondary Outcome Measure Information:
Title
Peak Pressure assessment
Description
Correlation between Peak Pressure assessment (inspiratory muscle endurance index) and duration of weaning period
Time Frame
Each 7 days (from inclusion day (day 1) to extubation day (maximum day 28))
Title
Maximal Inspiratory Pressure score assessment after weaning success
Description
Correlation between Maximal Inspiratory Pressure score assessment and weaning success (not re-intubated in the 48h post-extubation)
Time Frame
From inclusion day (day 1) to extubation success day (maximum day 28)
Title
Peak Pressure assessment after weaning success
Description
Correlation between Peak Pressure assessment and weaning success.
Time Frame
From inclusion day (day 1) to extubation success day (maximum day 28)
Title
Maximal Inspiratory Pressure score assessment and hospitalization
Description
Correlation between Maximal Inspiratory Pressure score assessment and intensive care unit length
Time Frame
From inclusion day (day 1) to come out of hospital day (maximum day 30)
Title
Peak Pressure assessment and hospitalization
Description
Correlation between Peak Pressure assessment and intensive care unit length
Time Frame
From inclusion day (day 1) to come out of hospital day (maximum day 30)
Title
Adverses events
Description
Adverses events occur during Maximal Inspiratory Pressure and Peak Pressure measures
Time Frame
Daily measures (from inclusion day (day 1) to come out of hospital day (maximum day 30))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient ventilated more than 18h in a controlled mode; First single breathe trial of 2 hours failure; Presence of sevrability criterias definied by the European consensus conference in 2007 as usually used: diminution of the sedfative agents ; Patients with spontaneous beath in VAC mode or patient ventilated in a VSAI-PEP mode; PaO2/FiO2 ≥150; Absence d'inotropes ou de vasopresseurs à forte dose ou dose croissante (<1mg/h); SaO2 > 90% with FiO2 ≤ 50%; PEP ≤ 8cmH2O; Corporal température between 36°C and 39°C; Glasgow Score ≥ 8; Patient or family consent. Exclusion Criteria: Age < 18 years ; medically unstable; Poor vital pronostic at very short term; Cardiac arrest with a poor neurological prognostic; Neuromuscular disease ; Tracheostomy ; Current pregnancy ; Patients with guardianship or trusteeship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perez Paul, Dr
Organizational Affiliation
USMR
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Haut-Lévêque
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Inspiratory Muscles Strength and Endurance Evolution on Difficult to Wean Patients in Intensive Care Unit

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