NCT01120574

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2010

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

10.2 years

First QC Date

March 19, 2010

Last Update Submit

March 21, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Nocturnal hypercapnic response to oxygenHome mechanical ventilationCOPD

Outcome Measures

Primary Outcomes (1)

  • Arterial pressure of CO2.

    Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.

    Six months

Secondary Outcomes (3)

  • Functional respiratory tests.

    Six months

  • Quality of life related to health

    6 months

  • Nocturnal hypoventilation (nocturnal pulseoxymetry)

    6 months

Study Arms (2)

1

NO INTERVENTION

Oxygen therapy group.

2

ACTIVE COMPARATOR

Home mechanical ventilation plus oxygen therapy group.

Other: Home mechanical ventilation

Interventions

Home mechanical ventilationOTHER

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

2

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2010

First Posted

May 11, 2010

Study Start

October 1, 2005

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

ES(1)