Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Study Overview
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Brief Summary
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A randomised study to assess the effectiveness of ambulatory adaptation to non-invasive mechanical ventilation in patient with hypercapnic respiratory failure secondary to neuromuscular diseases or alterations in thoracic cage in comparison with hospital adaptation.

Official Title
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A Randomized Trial to Compare the Effectiveness of Hospital or Ambulatory Approach for Adaptation to Non-Invasive Mechanical Ventilation in Patients With Chronic Respiratory Failure Secondary to Neuromuscular Diseases or Thoracic Cage Alterations

Conditions
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Chronic Respiratory Failure

Intervention / Treatment
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* Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
* Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 Chronic respiratory insufficiency secondary to neuromuscular disease or thoracic cage alterations with indication of non-invasive mechanical ventilation (presence of fatigue, dyspnea, morning headache, etc) plus one of the following criteria): PaCO2 > 45 mmHg Night time oxygen saturation < 88% at least for 5 consecutive minutes In neuromuscular diseases, PIM < 60 cmH2O or FVC < 50% of theoretical. Stable disease. Airway access through nasal mask. Ability to provide written informed consent. Ability to attend the visits Exclusion Criteria: Contraindications for mechanical ventilation: Patient with terminal disease or vegetative state Lack of motivation of the patient Lack of family or social support Patients clinically unstable Agitation or lack of co-operation Depression. Patients with acute symptoms requiring hospital admission. Need for airway access through tracheostomy, face mask or mouth piece. Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation. Use (for 7 days or more) of CNS depressors(benzodiazepines, antihistamines H1, tricyclic antidepressants , antiepileptic or antipsychotic drugs ) in the 30-day period prior to inclusion, or expected need for such drugs during the study. Lack of understanding of the study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Hospital based adaptation to non- invasive mechanical ventilation for 7 days | Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days<br>* Hospital based adaptation to non- invasive mechanical ventilation for 7 days<br>|
| Experimental: 2<br>Ambulatory adaptation to non- invasive mechanical ventilation for 7 days | Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days<br>* Ambulatory adaptation to non- invasive mechanical ventilation for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PaCO2 from baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PaCO2 from start of mechanical ventilation |  |  | 
| 6-minute walking test |  |  | 
| Adaptation failure |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory insufficiency, Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage