Comparison of the Impact of Three Programs of Inspiratory Muscles.

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

Interventions

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).

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).

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).

Sponsors & Collaborators

• University Hospital, Bordeaux

  lead OTHER

Principal Investigators

• Paul Perez, Professor · University Hospital, Bordeaux

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-15

Primary Completion

2020-02-22

Completion

2020-03-22

Countries

• France

Study Locations