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

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ClinicalTrials.gov Identifier: NCT03140267
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Weaning From Mechanical Ventilation Diagnostic Test: Difficult to wean patients Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Evolution of Force and Endurance of Inspiratory Muscles in Intubated and Mechanically-ventilated ICU Patients With Difficult Weaning
Actual Study Start Date : May 14, 2017
Estimated Primary Completion Date : January 14, 2020
Estimated Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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.




Primary Outcome Measures :
  1. Maximal Inspiratory Pressure score assessment [ Time Frame: Daily measure (from inclusion day (day 1) to extubation day (maximum day 28)) ]
    Correlation between Maximal Inspiratory Pressure score assessment (inspiratory muscle strength index) and duration of weaning period


Secondary Outcome Measures :
  1. Peak Pressure assessment [ Time Frame: Each 7 days (from inclusion day (day 1) to extubation day (maximum day 28)) ]
    Correlation between Peak Pressure assessment (inspiratory muscle endurance index) and duration of weaning period

  2. Maximal Inspiratory Pressure score assessment after weaning success [ Time Frame: From inclusion day (day 1) to extubation success day (maximum day 28) ]
    Correlation between Maximal Inspiratory Pressure score assessment and weaning success (not re-intubated in the 48h post-extubation)

  3. Peak Pressure assessment after weaning success [ Time Frame: From inclusion day (day 1) to extubation success day (maximum day 28) ]
    Correlation between Peak Pressure assessment and weaning success.

  4. Maximal Inspiratory Pressure score assessment and hospitalization [ Time Frame: From inclusion day (day 1) to come out of hospital day (maximum day 30) ]
    Correlation between Maximal Inspiratory Pressure score assessment and intensive care unit length

  5. Peak Pressure assessment and hospitalization [ Time Frame: From inclusion day (day 1) to come out of hospital day (maximum day 30) ]
    Correlation between Peak Pressure assessment and intensive care unit length

  6. Adverses events [ Time Frame: Daily measures (from inclusion day (day 1) to come out of hospital day (maximum day 30)) ]
    Adverses events occur during Maximal Inspiratory Pressure and Peak Pressure measures



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140267


Contacts
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Contact: Reginault Thomas 6 16 18 13 40 ext +33 thomas.reginault@chu-bordeaux.fr

Locations
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France
Hôpital Haut-Lévêque Recruiting
Bordeaux, France, 33000
Contact: Reginault Thomas    6 16 18 13 40 ext +33    thomas.reginault@chu-bordeaux.fr   
Hôpital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Reginault Thomas    6 16 18 13 40    thomas.reginault@chu-bordeaux.fr   
Principal Investigator: Vargas Frederic, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Perez Paul, Dr USMR

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03140267    
Other Study ID Numbers: CHUBX 2015/37
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Ventilated induced diaphragmatic dysfunction
Weaning
Inspiratory muscle training
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes