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CompletedNCT00698958Updated Jun 17, 2008

Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

A Phase 4 interventional study of Ambulatory adaptation to non- invasive mechanical ventilation for 7 days and Hospital based adaptation to non- invasive mechanical ventilation for 7 days in Chronic Respiratory Failure, sponsored by Hospital Clinic of Barcelona. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-06-17.

Sponsored by Hospital Clinic of Barcelona · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Respiratory Failure

Keywords

  • Respiratory insufficiency
  • Hypercapnic chronic respiratory failure secondary to neuromuscular diseases or alterations of thoracic cage
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 52 is close to the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Hospital Clinic of Barcelona is the lead sponsor of 319 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    1

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

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

  • Experimental
    2

    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

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

Interventions

  • ProcedureAmbulatory adaptation to non- invasive mechanical ventilation for 7 days

    Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

  • ProcedureHospital based adaptation to non- invasive mechanical ventilation for 7 days

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

06

What researchers measure

Primary outcomes

  1. Change in PaCO2 from baseline

    Time frame: 6 months

Secondary outcomes

  1. Change in PaCO2 from start of mechanical ventilation

  2. 6-minute walking test

  3. Adaptation failure

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 24837977 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00698958
Lead 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
First posted
Jun 17, 2008
Start date
Jun 2003
Last update
Jun 17, 2008

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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