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OpenTrials
Completed

NCT Number: NCT00698958

Ambulatory Adaptation to Non-Invasive Mechanical Ventilation

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

Procedure

Ambulatory adaptation to non- invasive mechanical ventilation for 7 days

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

Procedure

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

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

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Vall d'Hebron Research Institute

Registry information

Official study 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

Important dates

Study start
2003
First posted
Jun 17, 2008
Registry last updated
Jun 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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