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Completed

NCT Number: NCT00710463

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Berchtesgadener Land

Berchtesgaden, D-83471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Resmed VPAP III ST-A, Respironics Harmony

Primary outcomes

  1. six minute walk distance

    Time frame: beginning to end of rehabilitation

Secondary outcomes

  1. quality of life

    Time frame: beginning to end of rehabilitation

Sponsors and collaborators

Lead sponsor

Deutsche Lungenstiftung e.V.

Other

Collaborators

  • Hannover Medical School

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Jul 4, 2008
Registry last updated
Jul 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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