Status:

COMPLETED

AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Lead Sponsor:

ResMed

Collaborating Sponsors:

Royal Brompton & Harefield NHS Foundation Trust

Conditions:

Chest Wall Disorder

Neuromuscular Disease

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

Brief Summary

The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable ...

Eligibility Criteria

Inclusion

  • Patients aged 18-80 years
  • Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 \> 6.5 kPa when breathing spontaneously) with
  • Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
  • Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
  • All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403.
  • Able to understand treatment and protocol

Exclusion

  • Unstable respiratory failure (PaO2 \< 7.5 kPa, PaCO2 \> 8.0 kPa,
  • Uncontrolled heart failure or arrhythmia
  • Moderate or severe bulbar weakness.
  • Unable to understand treatment or protocol

Key Trial Info

Start Date :

November 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT00252252

Start Date

November 1 2005

End Date

December 1 2007

Last Update

June 24 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Royal Brompton Hospital

London, Greater London, United Kingdom, SW3 6NP