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Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response

NCT01120574 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-03-22

No results posted yet for this study

Summary

The objective of this study is to evaluate the clinical benefits of home mechanical ventilation associated to oxygen therapy in COPD patients with chronic respiratory failure (CRF) who develop hypercapnia and nocturnal respiratory acidosis secondary to oxygen administration.

We will include clinically stable COPD patients with hypercapnic CRF who develop a nocturnal hypercapnic response to oxygen (PaCO2 increase on awakening, at night with oxygen, \>10 mmHg respect to PaCO2 breathing room air and awake). Obstructive sleep apnoea syndrome (OSAS) will previously have been excluded.

Patients will be admitted to the Pneumology ward where a nocturnal pulsioxymetry breathing oxygen therapy will be performed. Arterial blood gas samples will be taken at awakening (7AM).

Patients who develop a hypercapnic response to oxygen will be randomised into 2 treatment groups:

* Oxygen therapy group
* Home mechanical ventilation plus oxygen therapy group Home mechanical ventilation will be performed with a bilevel pressure ventilator. Functional respiratory variables as well as quality of life and sleep at onset and after 6 months treatment will be compared.

The principal outcome will be the evolution of arterial blood gases (PaCO2) between the two groups.

Conditions

Interventions

OTHER

Home mechanical ventilation

Home mechanical ventilation will be performed with a bilevel pressure ventilator.

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120574 on ClinicalTrials.gov