Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

This study has been completed.
Sponsor:
Collaborators:
Hospital Universitari Vall d'Hebron Research Institute
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00698958
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008

June 13, 2008
June 16, 2008
June 2003
Not Provided
Change in PaCO2 from baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00698958 on ClinicalTrials.gov Archive Site
  • Change in PaCO2 from start of mechanical ventilation [ Designated as safety issue: No ]
  • 6-minute walking test [ Designated as safety issue: No ]
  • Adaptation failure [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Respiratory Failure
  • 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
  • Active Comparator: 1
    Hospital based adaptation to non- invasive mechanical ventilation for 7 days
    Intervention: Procedure: Hospital based adaptation to non- invasive mechanical ventilation for 7 days
  • Experimental: 2
    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
    Intervention: Procedure: Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Pallero M, Puy C, Güell R, Pontes C, Martí S, Torres F, Antón A, Muñoz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
Not Provided
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00698958
NEUMO/2002/01
No
Xavier Muñoz Gall, Hospitals Vall d'Hebron
Hospital Clinic of Barcelona
  • Hospital Universitari Vall d'Hebron Research Institute
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
Hospital Clinic of Barcelona
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP