Home Non Invasive Ventilation for COPD Patients (NIVOLD)

University Hospital, Rouen

Status: Enrolling

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Treatments: Device: Home ventilator

Study type: Interventional

Funder types: Other

Identifiers

NCT03221101

CPP-SC 010/2013 (Other Identifier)

2013-AO1276-39 2010/080/HP

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• severe obstructive sleep apnea ( DI > 30/h)
• Non COPD cause of respiratory failure
• Serious comorbidity
• Adverse psychological status

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 2 patient groups

Long Term Oxygen Therapy alone

No Intervention group

Description:

Long Term oxygen therapy is prescribed according to the guidelines

Non invasive ventilation

Active Comparator group

Description:

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

Treatment:

Device: Home ventilator