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

NCT03140267 | Completed

• 1 other identifier: CHUBX 2015/37
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Weaning From Mechanical Ventilation

Keywords

Ventilated induced diaphragmatic dysfunction; Weaning; Inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Peak Pressure assessment

  Each 7 days (from inclusion day (day 1) to extubation day (maximum day 28))

• Maximal Inspiratory Pressure score assessment after weaning success

  From inclusion day (day 1) to extubation success day (maximum day 28)

• Peak Pressure assessment after weaning success

  From inclusion day (day 1) to extubation success day (maximum day 28)

• Maximal Inspiratory Pressure score assessment and hospitalization

  From inclusion day (day 1) to come out of hospital day (maximum day 30)

• Peak Pressure assessment and hospitalization

  From inclusion day (day 1) to come out of hospital day (maximum day 30)

Study Arms (1)

Difficult to wean patients

EXPERIMENTAL

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

Diagnostic Test: Difficult to wean patients

Interventions

Difficult to wean patients 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.

Difficult to wean patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Hôpital Haut-Lévêque

Bordeaux, 33000, France

Location

Hôpital Pellegrin

Bordeaux, 33000, France

Location

Study Officials

• Perez Paul, Dr

  USMR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 4, 2017
• Study Start: May 14, 2017
• Primary Completion: January 23, 2020
• Study Completion: January 23, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)