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

NCT ID: NCT03140267

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-14
• Study Completion Date: 2020-01-23

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.

Conditions

Weaning From Mechanical Ventilation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Difficult to wean patients

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

Group Type: EXPERIMENTAL

Difficult to wean patients

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perez Paul, Dr

Role: STUDY_CHAIR

USMR

Locations

Hôpital Haut-Lévêque

Bordeaux, , France

Hôpital Pellegrin

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2015/37

Identifier Type: -

Identifier Source: org_study_id