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

NCT00710463 | Completed

• 1 other identifier: NIV and Rehabilitation
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD; non invasive ventilation; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• six minute walk distance

  beginning to end of rehabilitation

Secondary Outcomes (1)

• quality of life

  beginning to end of rehabilitation

Study Arms (2)

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)

Interventions

non invasive ventilation (Resmed VPAP III ST-A, Respironics Harmony) DEVICE

non invasive ventilation was performed with commercially available ventilators from the manufacturers Resmed and Respironics.

Also known as: Resmed VPAP III ST-A, Respironics Harmony

NIV treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Deutsche Lungenstiftung e.V.: lead
• Hannover Medical School: collaborator

Study Sites (1)

Klinikum Berchtesgadener Land

Berchtesgaden, D-83471, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Klaus Kenn, MD

  Klinikum Berchtesgadener Land

  STUDY DIRECTOR

• Ursula Schönheit-Kenn, ME

  Klinikum Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: May 1, 2003
• Primary Completion: September 1, 2007
• Study Completion: November 1, 2007
• Last Updated: July 4, 2008

Record last verified: 2008-07

Locations

DE (1)