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

NCT ID: NCT00710463

Last Updated: 2008-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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COPD non invasive ventilation pulmonary rehabilitation

Study Design

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Observational Model Type

COHORT

Study Groups

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Control group

patients receive a hospital based comprehensive pulmonary rehabilitation programme, including endurance training, physiotherapy, medical therapy, and long term oxygen treatment when indicated.

No interventions assigned to this group

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.

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Resmed VPAP III ST-A Respironics Harmony

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role collaborator

Deutsche Lungenstiftung e.V.

OTHER

Sponsor Role lead

Responsible Party

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Klinikum Berchtesgadener Land, Malterhöh 1, D-83471 Berchtesgaden

Principal Investigators

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Klaus Kenn, MD

Role: STUDY_DIRECTOR

Klinikum Berchtesgadener Land

Ursula Schönheit-Kenn, ME

Role: PRINCIPAL_INVESTIGATOR

Klinikum Berchtesgadener Land

Locations

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Klinikum Berchtesgadener Land

Berchtesgaden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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NIV and Rehabilitation

Identifier Type: -

Identifier Source: org_study_id