Home Non Invasive Ventilation for COPD 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

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2025-12-31

Brief Summary

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Chronic Obstructive Pulmonary Disease (COPD) patients are more likely to develop acute hypercapnic respiratory failure. In the acute phase, non invasive ventilation has been shown to improve mortality and reduce intubation rate. Few studies are available about long term benefits of home non invasive ventilation in COPD patients with chronic hypercapnic respiratory failure who survived after an acute episode. 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 acute hypercapnic respiratory failure episode treated by non invasive ventilation.

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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 alone

Long Term oxygen therapy is prescribed according to the guidelines

Group Type NO_INTERVENTION

No interventions assigned to this group

Non invasive ventilation

Home non invasive ventilation is prescribed with the following settings

* PS mode
* IPAP according to clinical and hemodynamic tolerance
* EPAP according to air trapping
* RR around 12/ min.
* LOT for SaO2 \> 90%
* Monitoring with capnometry for settings validation

Group Type ACTIVE_COMPARATOR

Home ventilator

Intervention Type DEVICE

Interventions

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Home ventilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* COPD patients who survived after an acute episode of hypercapnic respiratory failure
* patients weaned from ventilation ( non invasive ventilation or mechanical ventilation) prescribed for acute episode since at least five days with following arterial blood gas : pH \> 7.35 and PCO2 \> = 45 mmHg