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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Home mechanical ventilation
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Nocturnal hypercapnic response to oxygen, Home mechanical ventilation, COPD

Eligibility Criteria

undefined - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

Oxygen therapy group.

Home mechanical ventilation plus oxygen therapy group.

Outcomes

Primary Outcome Measures

Arterial pressure of CO2.
Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.

Secondary Outcome Measures

Functional respiratory tests.
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Quality of life related to health
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Nocturnal hypoventilation (nocturnal pulseoxymetry)
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).

Full Information

First Posted
March 19, 2010
Last Updated
March 21, 2017
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT01120574
Brief Title
Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Hypercapnic Response
Official Title
Home Mechanical Ventilation in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Develop Nocturnal Hypercapnic Response Associated to Oxygen Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Study Start Date
October 2005 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Nocturnal hypercapnic response to oxygen, Home mechanical ventilation, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Oxygen therapy group.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Home mechanical ventilation plus oxygen therapy group.
Intervention Type
Other
Intervention Name(s)
Home mechanical ventilation
Intervention Description
Home mechanical ventilation will be performed with a bilevel pressure ventilator.
Primary Outcome Measure Information:
Title
Arterial pressure of CO2.
Description
Follow up of its evolution comparing patients under O2 treatment and patients under O2 + non invasive ventilation treatment.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Functional respiratory tests.
Description
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Time Frame
Six months
Title
Quality of life related to health
Description
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Time Frame
6 months
Title
Nocturnal hypoventilation (nocturnal pulseoxymetry)
Description
Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

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

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