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Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698958
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
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

Tracking Information
First Submitted Date  ICMJE June 13, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date June 17, 2008
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Change in PaCO2 from baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Change in PaCO2 from start of mechanical ventilation
  • 6-minute walking test
  • Adaptation failure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ambulatory Adaptation to Non-Invasive Mechanical Ventilation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Chronic Respiratory Failure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2008)
52
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00698958
Other Study ID Numbers  ICMJE NEUMO/2002/01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xavier Muñoz Gall, Hospitals Vall d'Hebron
Study Sponsor  ICMJE Hospital Clinic of Barcelona
Collaborators  ICMJE
  • Hospital Universitari Vall d'Hebron Research Institute
  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators  ICMJE Not Provided
PRS Account Hospital Clinic of Barcelona
Verification Date June 2008

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