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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2014-A00319-38 |
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departure of the coordinating investigator from another institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental |
| |
| control | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive mechanical ventilation - Normoxia | Device | Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%) |
| Measure | Description | Time Frame |
|---|---|---|
| urinary output (ml) | First 24 hours of non-invasive mechanical ventilation | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in CO2 levels | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| respiratory workload during non-invasive mechanical ventilation (occlusion pressure (cm H2O) to 100 ms after the onset of inspiration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael DARMON, MD PhD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de CLERMONT-FERRAND | Clermont-Ferrand | 63000 | France | |||
| CHu de GRENOBLE |
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| Non-invasive mechanical ventilation - Controlled hypoxemia | Device | Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%) |
|
First 24 hours of non-invasive mechanical ventilation
| 24 hours, 48 hours, 72 hours |
| Serum creatinine | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| Renal resistive index | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| Pulmonary arterial pressure | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| Semiquantitative assessment of dyspnea (visual likert scale) | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| Semiquantitative assessment of comfort (visual likert scale) | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| Fluid balance | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| SOFA (Sequential Organ Failure Assessment) score | First 24 hours of non-invasive mechanical ventilation | 24 hours, 48 hours, 72hours |
| Mortality | First 24 hours of non-invasive mechanical ventilation | up to day 28 |
| Number of patients requiring mechanical ventilation | Evaluation until 28 days with an evaluation at intensive care unit discharge, and at hospital discharge | up to day 28 |
| days alive without mechanical ventilation | Evaluation up to 28 days with an evaluation at intensive care unit discharge, and at hospital discharge | up to day 28 |
| Grenoble |
| 38000 |
| France |
| CHU de la Pitié-Salpêtrière | Paris | 75013 | France |
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D006935 | Hypercapnia |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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