Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy|
- Arterial pressure of CO2. [ Time Frame: Six months ]Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.
- Functional respiratory tests. [ Time Frame: Six months ]Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
- Quality of life related to health [ Time Frame: 6 months ]Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
- Nocturnal hypoventilation (nocturnal pulseoxymetry) [ Time Frame: 6 months ]Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
|Actual Study Start Date:||October 2005|
|Study Completion Date:||December 2015|
|Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
No Intervention: 1
Oxygen therapy group.
Active Comparator: 2
Home mechanical ventilation plus oxygen therapy group.
Other: Home mechanical ventilation
Home mechanical ventilation will be performed with a bilevel pressure ventilator.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120574
|Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau|
|Barcelona, Spain, 08025|