Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Hypercapnic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long Term Oxygen Therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Non Invasive Ventilation

Group Type ACTIVE_COMPARATOR

Non Invasive Ventilation

Intervention Type DEVICE

NIV during night

Interventions

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Non Invasive Ventilation

NIV during night

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years old
* COPD patients who survived after an episode of acute hypercapnic respiratory failure
* Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 \> 55 mmHg and pH \> 7.35

Exclusion Criteria

* Age \> 85 years old
* Non- COPD causes of respiratory failure
* Obstructive sleep apnea excluded by polysomnography
* Adverse psychosocial status
* Serious co-morbidity

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No