Comparison of Two Oxygen Setting During Non-invasive Mechanical Ventilation of Chronic Obstructive Pulmonary Disease
- Conditions
- Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
- Interventions
- Device: Non-invasive mechanical ventilation - Controlled hypoxemiaDevice: Non-invasive mechanical ventilation - Normoxia
- Registration Number
- NCT02563314
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control Non-invasive mechanical ventilation - Controlled hypoxemia - intervention Non-invasive mechanical ventilation - Normoxia -
- Primary Outcome Measures
Name Time Method urinary output (ml) 24 hours First 24 hours of non-invasive mechanical ventilation
- Secondary Outcome Measures
Name Time Method Serum creatinine 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
Renal resistive index 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
Changes in CO2 levels 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
Fluid balance 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
SOFA (Sequential Organ Failure Assessment) score 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration) 24 hours, 48 hours, 72 hours First 24 hours of non-invasive mechanical ventilation
Semiquantitative assessment of comfort (visual likert scale) 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
Pulmonary arterial pressure 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
Mortality up to day 28 First 24 hours of non-invasive mechanical ventilation
Semiquantitative assessment of dyspnea (visual likert scale) 24 hours, 48 hours, 72hours First 24 hours of non-invasive mechanical ventilation
Number of patients requiring mechanical ventilation up to day 28 Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
days alive without mechanical ventilation up to day 28 Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge
Trial Locations
- Locations (4)
CHU de la Pitié-Salpêtrière
🇫🇷Paris, France
CHU de CLERMONT-FERRAND
🇫🇷Clermont-ferrand, France
CHU de SAINT-ETIENNE
🇫🇷Saint-etienne, France
CHu de GRENOBLE
🇫🇷Grenoble, France