Australian Trial of Ventilation in Chronic Airflow Limitatio

Completed

• Conditions: Chronic airflow limitation; Respiratory - Other respiratory disorders / diseases

• Registration Number: ACTRN12605000205639
• Lead Sponsor: Professor RD McEvoy MD, MBBS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Chronic Airflow Limitation (FEV1< 1.5 or < 50% Predicted; FEV1/FVC < 60%, TLC > 92%; FEV1 with bronchodilators < 20%)+Daytime awake PaCO2 >46 mm Hg at least twice in the previous 6 months during periods of clinical stability;+Willing and competent to sign informed consent.+Under 80 years of age+On oxygen therapy for a minimum of three months prior to enrollment.

Exclusion Criteria

Serious coexisting disease (eg. left ventricular failure, malignancy, renal failure, unstable angina) likely to affect survival during the study period+Significant Obstructive Sleep Apnea (defined as Apnoea/hypopoea index >20/h) or Obesity Hypoventilation Syndrome +Significant recent psychological or psychiatric problems likely to significantly impair ability to participate in the study and comply with treatment; +Previous treatment with NIV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival[At 2 years.]

Secondary Outcome Measures

Name	Time	Method
Daytime blood gases[Measured at 6 monthly intervals];Lung function[Measured at 6 monthly intervals];Treatment compliance[Measured at 6 monthly intervals];Quality of life[Measured at 6 monthly intervals]