Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Evaluation of the Role of Nocturnal Non-Invasive Ventilation in Pulmonary Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710463
• Other study ID #: NIV and Rehabilitation
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: July 3, 2008
• Start date: May 2003
• Est. completion date: November 2007

Study information

• Verified date: July 2008
• Source: Deutsche Lungenstiftung e.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Hypothesis: Hospital based, comprehensive pulmonary rehabilitation of patients with COPD in GOLD stage IV can be optimized by application of nocturnal non invasive ventilation.

This hypotheses shall be tested by an observational trial, comparing rehabilitation effects of a prospectively observed group receiving non invasive ventilation, compared wiht a historical control group of patients who did received the same treatment without non invasive ventilation.

Description:

Non invasive ventilation is known to allow improvements if applied during endurance training, but this is technically difficult. Nocturnal application of non invasive ventilation is known to unload the ventilatory pump, reset the control of breathing, and improve sleep quality.

The protocol also aimed to evaluate the acceptance of non invasive ventilation in patients undergoing a four week inpatient pulmonary rehabilitation programme.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of COPD in stages GOLD IV

• Receiving optimized medical treatment and long term oxygen treatment, if indicated

• Patient's consent to participate in this trial

Exclusion Criteria:

• Previous treatment with NIPPV

• Unwillingness or intolerance to perform NIPPV

• Acute exacerbation of COPD at baseline or during pulmonary rehabilitation,

• Significant orthopaedic or neurologic problems that reduce mobility or cooperation with physical training

• Poor controlled coexisting psychiatric or unstable cardiac disease,

• Inability to perform a six minute walk test

• Extreme hypercapnia (pCO2 > 74 mmHg)

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)
non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.

Locations

Country	Name	City	State
Germany	Klinikum Berchtesgadener Land	Berchtesgaden

Sponsors (2)

Lead Sponsor	Collaborator
Deutsche Lungenstiftung e.V.	Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six minute walk distance		beginning to end of rehabilitation	No
Secondary	quality of life		beginning to end of rehabilitation	No