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

Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning

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.

Study Overview

• Status: Completed
• Conditions: Weaning From Mechanical Ventilation
• Intervention / Treatment: Diagnostic test: Difficult to wean patients

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Hôpital Pellegrin
  • Bordeaux, France, 33000
    • Hôpital Haut-Lévêque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Difficult to wean patients; Maximal Inspiratory Pressure and Peak Pressure from the inclusion day to the extubation day will be measure.	Diagnostic test: Difficult to wean patients; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal Inspiratory Pressure score assessment	Correlation between Maximal Inspiratory Pressure score assessment (inspiratory muscle strength index) and duration of weaning period	Daily measure (from inclusion day (day 1) to extubation day (maximum day 28))

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Pressure assessment	Correlation between Peak Pressure assessment (inspiratory muscle endurance index) and duration of weaning period	Each 7 days (from inclusion day (day 1) to extubation day (maximum day 28))
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)	From inclusion day (day 1) to extubation success day (maximum day 28)
Peak Pressure assessment after weaning success	Correlation between Peak Pressure assessment and weaning success.	From inclusion day (day 1) to extubation success day (maximum day 28)
Maximal Inspiratory Pressure score assessment and hospitalization	Correlation between Maximal Inspiratory Pressure score assessment and intensive care unit length	From inclusion day (day 1) to come out of hospital day (maximum day 30)
Peak Pressure assessment and hospitalization	Correlation between Peak Pressure assessment and intensive care unit length	From inclusion day (day 1) to come out of hospital day (maximum day 30)
Adverses events	Adverses events occur during Maximal Inspiratory Pressure and Peak Pressure measures	Daily measures (from inclusion day (day 1) to come out of hospital day (maximum day 30))

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Perez Paul, Dr, USMR

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2017
• Primary Completion (Actual): January 23, 2020
• Study Completion (Actual): January 23, 2020

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Weaning; Inspiratory muscle training; Ventilated induced diaphragmatic dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: CHUBX 2015/37; 2016-A01137-44 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No