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

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Berchtesgaden, Germany, D-83471
    • Klinikum Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients were recruited at a single center, the rehabilitation hospital "Klinikum Berchtesgadener Land" at Germany.

Patients entering the well defined, hospital based pulmonary rehabilitation programme after Januar 1, 2005 were additionally treated with nocturnal non invasive ventilation. The results of these patients were compared with a group of patients who underwent the same rehabilitation programme in the years 2003 to 2005, when non invasive ventilation was not availabe.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated.
NIV treatment group; patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated, plus newly introduced nocturnal non invasive ventilation.	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.; Other Names: Resmed VPAP III ST-A; Respironics Harmony

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
six minute walk distance	beginning to end of rehabilitation

Secondary Outcome Measures

Outcome Measure	Time Frame
quality of life	beginning to end of rehabilitation

Collaborators and Investigators

• Sponsor: Deutsche Lungenstiftung e.V.
• Collaborators: Hannover Medical School
• Investigators: Study Director: Klaus Kenn, MD, Klinikum Berchtesgadener Land; Principal Investigator: Ursula Schönheit-Kenn, ME, Klinikum Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start: May 1, 2003
• Primary Completion (Actual): September 1, 2007
• Study Completion (Actual): November 1, 2007

Study Registration Dates

• First Submitted: July 2, 2008
• First Submitted That Met QC Criteria: July 3, 2008
• First Posted (Estimate): July 4, 2008

Study Record Updates

• Last Update Posted (Estimate): July 4, 2008
• Last Update Submitted That Met QC Criteria: July 3, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: COPD; pulmonary rehabilitation; non invasive ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: NIV and Rehabilitation