Weaning From Mechanical Ventilation Clinical Trial
Official title:
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.
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.
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