Clinical trial NCT00698958: Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Respiratory Failure
Keywords: Respiratory insufficiency
Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Hospital Universitari Vall d'Hebron Research Institute
name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
First posted: 2008-06-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 75
2. 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.
3. Stable disease.
4. Airway access through nasal mask.
5. Ability to provide written informed consent.
6. Ability to attend the visits

Exclusion Criteria:

1. 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.
2. Patients with acute symptoms requiring hospital admission.
3. Need for airway access through tracheostomy, face mask or mouth piece.
4. Relevant comorbidity (ie. heart failure, diabetes non controlled, infections, malignancies, etc.) leading to difficulties in adaptation to ventilation.
5. 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.
6. Lack of understanding of the study procedures.

Primary outcomes:
measure: Change in PaCO2 from baseline
timeFrame: 6 months
Secondary outcomes:
measure: Change in PaCO2 from start of mechanical ventilation
measure: 6-minute walking test
measure: Adaptation failure
Other outcomes:
Locations:
Study officials:
References:
citation: 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.