Comparison of the Impact of Three Programs of Inspiratory Muscles. (PREDRIC)

Comparison of the Incidence of 3 Inspiratory Muscle Training Programs on Inspiratory Strength, on Difficult to Wean Patients in Intensive Care Unit: a Multi-centre Randomised Trial.

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.

In this study, the investigators want to compare the incidence of 3 inspiratory muscle training programs on inspiratory strength, on difficult to wean patients in intensive care unit.

This is a multi-center randomized trial not blinded with 3 parallels groups:

• Martin's group: a threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.
• Cader's group: a threshold-based IMT is performed like used by Cader in a randomized trial in 2010 , in a view of inspiratory endurance increase.
• EDRIC's group: a new treshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.

The investigators think that a new threshold-based IMT performed in a view of both inspiratory strength and endurance increase, is more effective and well tolerated than the 2 others protocols.

Study Overview

• Status: Completed
• Conditions: Weaning From Mechanical Ventilation
• Intervention / Treatment: Procedure: Martin; Procedure: Cader; Procedure: EDRIC

Detailed Description

The main objective of this study is to determinate which IMT program is the most effective on the inspiratory muscle strength and endurance increase. The investigators will be able to study the impact on the weaning time of IMT performed with the best protocol.

The investigators are going to conduct a randomized trial with intention-to-treat analysis. 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, 88 participants will be included. Participants will be randomizesd to receive one of the 3 protocols of IMT, 2 times per day, 7 days per week, from the inclusion to the extubation.

The ratio of randomization will be 1:1:2 for a better evaluation of EDRIC's group wich propose a new IMT protocol.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Réanimation médicale
  • Lyon, France, 69004
    • Réanimation médicale

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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 an 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Martin; A threshold-based IMT is performed like used by Martin in a randomized trial in 2011, in a view of inspiratory strength increase.	Procedure: Martin; The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to the higher resistance tolerated by the patient in a set of 6 breaths. Participant repeats 4 sets of 6-10 breaths with 2 minutes of resting with mechanical ventilation between each set. This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150).
Active Comparator: Cader; A threshold-based IMT is performed like used by Cader in a randomized trial in 2012, in a view of inspiratory endurance increase.	Procedure: Cader; The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to 30% of the Maximal Inspiratory Pressure initially recorded the day of the inclusion. Participant breaths against this resistance during 5 minutes. The resistance is daily increased of 10 % to the higher tolerated. This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150).
Experimental: EDRIC; A new threshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.	Procedure: EDRIC; The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance at 30% of the Maximal Inspiratory Pressure of the day for the first set of 20 breaths with a resistance 's increasment of 10% at each set. Participant repeats 4 sets of 20 breaths with 2 minutes of resting with mechanical ventilation between each set. This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal Inspiratory Pressure score (inspiratory muscle strength index) performed by an external electronic device connected with a unidirectional valve.	Baseline and up to day 25

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Day 30
Peak Pressure (inspiratory muscle endurance index) performed by an incremental threshold test.	Baseline and up to day 25
Duration of the weaning period	up to day 25
ICU lengh of stay	Day 30
Weaning success	up to day 27

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2016
• Primary Completion (Actual): February 22, 2020
• Study Completion (Actual): March 22, 2020

Study Registration Dates

• First Submitted: July 28, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Intensive care unit; Weaning; inspiratory muscles training programs; Ventilator-induced diaphragmatic dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: CHUBX2015/25

Plan for Individual participant data (IPD)

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