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| Name | Class |
|---|---|
| Hospital Universitari Vall d'Hebron Research Institute | OTHER |
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Hospital based adaptation to non- invasive mechanical ventilation for 7 days |
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| 2 | Experimental | Ambulatory adaptation to non- invasive mechanical ventilation for 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory adaptation to non- invasive mechanical ventilation for 7 days | Procedure | Ambulatory adaptation to non- invasive mechanical ventilation for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PaCO2 from baseline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in PaCO2 from start of mechanical ventilation | ||
| 6-minute walking test | ||
| Adaptation failure |
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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):
Stable disease.
Airway access through nasal mask.
Ability to provide written informed consent.
Ability to attend the visits
Exclusion Criteria:
Contraindications for mechanical ventilation:
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.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24837977 | Derived | Pallero M, Puy C, Guell R, Pontes C, Marti S, Torres F, Anton A, Munoz X. Ambulatory adaptation to noninvasive ventilation in restrictive pulmonary disease: a randomized trial with cost assessment. Respir Med. 2014 Jul;108(7):1014-22. doi: 10.1016/j.rmed.2014.04.016. Epub 2014 May 2. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Hospital based adaptation to non- invasive mechanical ventilation for 7 days | Procedure | Hospital based adaptation to non- invasive mechanical ventilation for 7 days |
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