Bi-level Ventilatory Support during exacerbations of Cystic Fibrosis

Randomised trial of short-term effects of bi-level ventilatory support (BVS) on lung function, gas exchange, exercise capacity, quantitative sputum microbiology and quality of life during an exacerbation of Cystic Fibrosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000437662

Enrollment

Registered

2005-09-16

Start date

2003-10-09

Completion date

2006-06-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial was completed recruitment in 2006 and data collection (for time-to-next readmission in 2015. Manuscript was published in the Journal of Physiotherapy 2015, vol 61:142-147.

Interventions

Patients will be randomised to receive BVS in combination with standard therapy or not throughout a hospital admission for an acute respiratory exacerbation. BVS will be applied when the patient is awake, as an adjunct to chest physiotherapy with a physiotherapist, and for self use for physiotherapy or dyspnoea relief.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

17 Years to No maximum

Healthy volunteers

Inclusion criteria

Acute respiratory exacerbation of Cystic Fibrosis (Fuchs et al 1994) requiring IV antibiotics and admission to hospital; aged over 17 years; FEV1 <60% predicted on admission.

Exclusion criteria

Already using BVS or daytime respiratory failure on admission; problem pneumothoraces; recent massive haemoptysis; pregnant; sputum colonised with burkolderia cepacia; previous participation in this study; admitted for lung transplant work-up.

Outcome results