Chronic Obstructive Pulmonary Disease With Acute Exacerbation, Unspecified
Conditions
Keywords
Noninvasive Ventilation, Pulmonary Disease, Chronic Obstructive, Renal Doppler, Oxygen, Hypercapnia
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.
Interventions
DEVICENon-invasive mechanical ventilation - Normoxia
Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)
DEVICENon-invasive mechanical ventilation - Controlled hypoxemia
Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urinary output (ml) | 24 hours | First 24 hours of non-invasive mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Pulmonary arterial pressure | 24 hours, 48 hours, 72hours | 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 |
| 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 |
| Mortality | up to day 28 | 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 |
| Semiquantitative assessment of comfort (visual likert scale) | 24 hours, 48 hours, 72hours | First 24 hours of non-invasive mechanical ventilation |
Countries
France
Outcome results
None listed