Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia (OPPAÎ)
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|ClinicalTrials.gov Identifier: NCT03527992|
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : November 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia Pneumonia, Ventilator-Associated Length of Stay||Device: O2 automated Device: O2 standard||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia|
|Actual Study Start Date :||March 9, 2018|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||September 2021|
Automated oxygen therapy
An automated oxygen therapy is a system that allows administration of oxygen with a flow that is automatically adjusted to the patient's saturation, which is continuously monitored. Patients will receive O2 automated intervention.
Device: O2 automated
In the "O2 automated" group, patients benefit from oxygen therapy via the "FreeO2" device. The O2 saturation target is set by the clinician on the device. Saturation is continuously sensed by an oximeter and the oxygen flow is automatically adjusted. The clinician has access to instantaneous values and trends of O2 and SpO2 flow rates.
Standard Oxygen therapy
Patients will receive O2 standard therapy
Device: O2 standard
In the "O2 standard" group, patients benefit from oxygen therapy with nasal goggles or a high concentration mask. Saturation is continuously captured by an oximeter. The flow rate of oxygen, evaluated in L/min, is adapted according to local protocols (every 8 hours in conventional hospital services, continuous in intensive care
- Length in days of hospital stay [ Time Frame: 1 month ]measure of total days of hospitalization and intensive care
- Duration of oxygen therapy [ Time Frame: 1 month ]Oxygen therapy time evaluation during hospitalization of patient
- Time spent outside of the target saturation [ Time Frame: 1 month ]Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,
- the cost on the medical-economic level [ Time Frame: 1 month ]investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
- rate of medical complication [ Time Frame: 1 month ]Investigator want to evaluate the rate of medical complication between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
- quality questionnaire of patient's life during hospitalization [ Time Frame: 1 month ]Investigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527992
|Contact: Elise Noel-Savina, MD||5 67 77 16 90 ext firstname.lastname@example.org|
|Toulouse, France, 31049|
|Contact: Elise Noel-Savina, MD 5 67 77 16 90 ext 33 email@example.com|
|Principal Investigator: Elise Noel-Savina, MD|
|Sub-Investigator: Sandrine Pontier-Marchandise, MD|
|Sub-Investigator: Alain Didier, MD|
|Principal Investigator:||Elise Noel-Savina, MD||University Hospital, Toulouse|