Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Interventions Used in this Clinical Trial

  • Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
    • Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
  • Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days
    • Hospital based adaptation to non- invasive mechanical ventilation for 7 days

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • Hospital based adaptation to non- invasive mechanical ventilation for 7 days
  • Experimental: 2
    • Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in PaCO2 from baseline
    • Time Frame: 6 months
      Safety Issue?: No

Secondary Measures

  • Change in PaCO2 from start of mechanical ventilation
    • Safety Issue?: No
  • 6-minute walking test
    • Safety Issue?: No
  • Adaptation failure
    • Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Hospital Clinic of Barcelona
  • Collaborator
    • Hospital Universitari Vall d’Hebron Research Institute
  • Provider of Information About this Clinical Study
    • Xavier Muñoz Gall, Hospitals Vall d’Hebron

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00698958