Comparison of the Impact of Three Programs of Inspiratory Muscles. (NCT02855619) | Clinical Trial Compass
CompletedNot Applicable
Comparison of the Impact of Three Programs of Inspiratory Muscles.
France92 participantsStarted 2016-10-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal Inspiratory Pressure score (inspiratory muscle strength index) performed by an external electronic device connected with a unidirectional valve.