Home Mechanical Ventilation in Patients With Chronic Obst... | NCT01120574

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005Actual

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 19, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	Oxygen therapy group.
2	Active Comparator	Home mechanical ventilation plus oxygen therapy group.	Other: Home mechanical ventilation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home mechanical ventilation	Other	Home mechanical ventilation will be performed with a bilevel pressure ventilator.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Functional respiratory tests.	Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).	Six months
Quality of life related to health	Evolution during a follow up of 6 months between both groups (O2 vs O2+NIV).

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundació Institu de Recerca de l'Hospital de la Santa Creu i Sant Pau		Barcelona	Barcelona	08025	Spain

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms