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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor:
Information provided by (Responsible Party):
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: February 21, 2014
Last verified: February 2014
  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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Fundació Institut de Recerca de l'Hospital de la 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: February 21, 2014
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 July 24, 2014