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Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

Primary Purpose

Chronic Respiratory Failure

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
Hospital based adaptation to non- invasive mechanical ventilation for 7 days
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Respiratory Failure focused on measuring Respiratory insufficiency, Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    1

    2

    Arm Description

    Hospital based adaptation to non- invasive mechanical ventilation for 7 days

    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

    Outcomes

    Primary Outcome Measures

    Change in PaCO2 from baseline

    Secondary Outcome Measures

    Change in PaCO2 from start of mechanical ventilation
    6-minute walking test
    Adaptation failure

    Full Information

    First Posted
    June 13, 2008
    Last Updated
    June 16, 2008
    Sponsor
    Hospital Clinic of Barcelona
    Collaborators
    Hospital Universitari Vall d'Hebron Research Institute, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00698958
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hospital Clinic of Barcelona
    Collaborators
    Hospital Universitari Vall d'Hebron Research Institute, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Respiratory Failure
    Keywords
    Respiratory insufficiency, Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Hospital based adaptation to non- invasive mechanical ventilation for 7 days
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
    Intervention Type
    Procedure
    Intervention Name(s)
    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
    Intervention Description
    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days
    Intervention Type
    Procedure
    Intervention Name(s)
    Hospital based adaptation to non- invasive mechanical ventilation for 7 days
    Intervention Description
    Hospital based adaptation to non- invasive mechanical ventilation for 7 days
    Primary Outcome Measure Information:
    Title
    Change in PaCO2 from baseline
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Change in PaCO2 from start of mechanical ventilation
    Title
    6-minute walking test
    Title
    Adaptation failure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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): 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. Stable disease. Airway access through nasal mask. Ability to provide written informed consent. Ability to attend the visits Exclusion Criteria: 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. 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24837977
    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.
    Results Reference
    derived

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