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

Deutsche Lungenstiftung e.V.

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

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

Study type: Observational

Funder types: Other

Identifiers

NCT00710463

NIV and Rehabilitation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

80 participants in 2 patient groups

Control group

Description:

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

Description:

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.

Treatment:

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