Comparison of the Impact of Three Programs of Inspiratory Muscles.

NCT02855619 | Completed

• 1 other identifier: CHUBX2015/25
• Study Type: interventional
• Target: 92
• 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. 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.

Conditions

Weaning From Mechanical Ventilation

Keywords

inspiratory muscles training programs; Ventilator-induced diaphragmatic dysfunction; Weaning; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Adverse events

  Day 30

Study Arms (3)

Martin

ACTIVE COMPARATOR

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

Cader

ACTIVE COMPARATOR

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

EDRIC

EXPERIMENTAL

A new threshold-based IMT is performed, in a view of both inspiratory strength and endurance increase.

Procedure: EDRIC

Interventions

Martin PROCEDURE

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).

Martin

Cader PROCEDURE

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).

Cader

EDRIC PROCEDURE

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).

EDRIC

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 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.

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 ;
• Pneumothorax non drained ;
• Tracheostomy ;
• Current pregnancy ;
• Patients with guardianship or trusteeship.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Réanimation Médicale

Bordeaux, 33076, France

Location

Réanimation Médicale

Lyon, 69004, France

Location

Related Publications (1)

• Reginault T, Martinez Alejos R, Coueron R, Burle JF, Boyer A, Frison E, Vargas F. Impacts of three inspiratory muscle training programs on inspiratory muscles strength and endurance among intubated and mechanically ventilated patients with difficult weaning: a multicentre randomised controlled trial. J Intensive Care. 2024 Jul 25;12(1):28. doi: 10.1186/s40560-024-00741-3.

  PMID: 39049092 DERIVED

Study Officials

• Paul Perez, Professor

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 4, 2016
• Study Start: October 15, 2016
• Primary Completion: February 22, 2020
• Study Completion: March 22, 2020
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)