Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease

NCT ID: NCT02563314

Last Updated: 2019-06-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2018-09-24

Brief Summary

Hypoxaemic patients with exacerbations of chronic obstructive pulmonary disease (COPD) are at some risk of carbon dioxide (CO2) retention during oxygen therapy. Main mechanism of CO2 retention is believed to be reversal of preexisting regional hypoxic pulmonary vasoconstriction, resulting in a greater dead space. Risk of CO2 retention during mechanical ventilation remains controversial. Thus recent study suggested limited risk of CO2 retention with controlled oxygen supplementation during mechanical ventilation. Conversely, controlled oxygen supplementation might decrease dyspnea and respiratory workload, increase comfort and improve both urinary output and renal function.

Conditions

Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

intervention

Group Type: EXPERIMENTAL

Non-invasive mechanical ventilation - Normoxia

Intervention Type: DEVICE

Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)

control

Group Type: OTHER

Non-invasive mechanical ventilation - Controlled hypoxemia

Intervention Type: DEVICE

Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)

Interventions

Non-invasive mechanical ventilation - Normoxia

Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)

Intervention Type: DEVICE

Non-invasive mechanical ventilation - Controlled hypoxemia

Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years
• Acute hypercapnic COPD exacerbation
• Respiratory acidosis
• Intensive care unit admission
• Non-Invasive mechanical ventilation for less than 24 hours
• Patients or proxy consent
• Patients affiliated with the General Social Security Health System

Exclusion Criteria

• Pregnancy
• Sickle cells disease
• Acute coronary syndrome
• Restrictive respiratory disease
• Stage 4 or 5 chronic kidney disease
• COPD exacerbation following a first episode of conventional mechanical ventilation
• Contraindications to non-invasive ventilation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael DARMON, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de CLERMONT-FERRAND

Clermont-Ferrand, , France

CHu de GRENOBLE

Grenoble, , France

CHU de la Pitié-Salpêtrière

Paris, , France

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1408025

Identifier Type: -

Identifier Source: org_study_id