Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT01120574
First received: March 19, 2010
Last updated: January 19, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease |
Other: Home mechanical ventilation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Primary Outcome Measures:
- Arterial pressure of CO2. [ Time Frame: Six months ] [ Designated as safety issue: No ]Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.
Secondary Outcome Measures:
- Functional respiratory tests. [ Time Frame: Six months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
- Nocturnal hypoventilation (nocturnal pulseoxymetry) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
| Estimated Enrollment: | 47 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | up to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Elderly patients < 80 years old.
- COPD (ERS/ATS (FEV1 < 80%, FEV1/FVC < 70%, TLC > 80%)).
- Oxygen therapy indication (PaO2 < 55 mmHg or 55-59 associated to pulmonary arterial hypertension, chronic Cor Pulmonale, Chronic Heart failure, arrhythmias or polyglobulia).
- PaCO2 > 50 mm Hg.
- Clinically stable at least prior to one month.
- Hypercapnic response: increasing PaCO2 > 10 mmHg at 7 a.m after all night with oxygen compared with PaCO2 when awake and without oxygen therapy.
Exclusion Criteria:
- Active smoker.
- Bronchiectasis or tuberculous after-effects.
- Chronic respiratory failure secondary to thorax cage or neuromuscular diseases.
- BMI > 35 kg/m2
- OSAS.
- Locomotor system problems that disable 6 minutes walking test execution.
- Patients with tracheostomy.
- Other serious comorbidity (i.e chronic heart failure functional class > II NYHA, cancer or chronic renal failure that requires dialysis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120574
Contacts
| Contact: Pedro Antonio A Anton, Medical Doctor | +034935575972 ext - | PAnton@santpau.cat |
| Contact: M Carme C Puy, Physician | +034935575972 ext . | MPuyR@santpau.cat |
Locations
| Spain | |
| Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain, 08025 | |
| Contact: Pedro Antonio A Anton, Medical Doctor +034935575972 ext - PAnton@santpau.cat | |
| Contact: M Carme C Puy, Physician +034935575972 ext - MPuyR@santpau.cat | |
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
More Information
No publications provided
| Responsible Party: | Carme Puy Rion, Hospital del a Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT01120574 History of Changes |
| Other Study ID Numbers: | PR05/05/2007 |
| Study First Received: | March 19, 2010 |
| Last Updated: | January 19, 2011 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
|
Nocturnal hypercapnic response to oxygen Home mechanical ventilation COPD |
Additional relevant MeSH terms:
|
Hypercapnia Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Signs and Symptoms, Respiratory Signs and Symptoms Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 13, 2013