Respiratory Muscle Training in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.

Official Title
-----------------
Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation

Conditions
-----------------
Critical Illness, Inspiratory Muscle Strength, Mechanical Ventilation, Respiratory Muscle Training

Intervention / Treatment
-----------------
* Procedure: inspiratory and expiratory muscle training
* Procedure: inspiratory and expiratory exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient from mechanical ventilation after at least 24 hours of support collaborative patient Exclusion Criteria: confusion, mental disorder not french speaking pulmonary surgery in the past 12 months external ventricular drain previous pneumothorax or pneumothorax not drained rib fractures alveolar hemorrhage hemodynamic instability labial occlusion impossible (face burn, facial paralysis) patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trained group<br>Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week. Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge | Procedure: inspiratory and expiratory muscle training<br>* inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water<br>|
| Placebo Comparator: Untrained group<br>Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week. Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm) Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge | Procedure: inspiratory and expiratory exercises<br>* inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in inspiratory muscle strength | measurement of maximal inspiratory pressure | between 7 to 15 days after ICU discharge (compared to ICU discharge) | 
| change in inspiratory muscle strength | measurement of maximal inspiratory pressure | 1 month after ICU discharge (compared to ICU discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in expiratory muscle strength | measurement of maximal expiratory pressure | between 7 to 15 days after ICU discharge (compared to ICU discharge) | 
| change in expiratory muscle strength | measurement of maximal expiratory pressure | 1 month after ICU discharge (compared to ICU discharge) | 
| respiratory infections | number of respiratory infections requiring antibiotics after ICU discharge | 1 month after ICU discharge | 
| change in dyspnea perception | assessed using Dyspnea-12 questionnaire (score from 0 to 36, 36 indicating a maximal dyspnea) | 1 month after ICU discharge (compared to hospital discharge) | 
| impact of dyspnea on physical activities | assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing) | between 7 to 15 days after ICU discharge | 
| impact of dyspnea on physical activities | assessed using modified Medical Research Council (m-MRC) score: stage 0 to 4 (last stage indicating a patient too dyspneic to leave house or breathless when dressing) | 1 month after ICU discharge |