Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients (NIVOLD)

University Hospital, Rouen

Status: Terminated

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Treatments: Device: Non Invasive Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01526642

2010/080/HP

Details and patient eligibility

About

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).

Enrollment: 12 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Long Term Oxygen Therapy

No Intervention group

Non Invasive Ventilation

Active Comparator group

Treatment:

Device: Non Invasive Ventilation