Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

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Sponsorii

University Hospital, Toulouse

STUDIU CLINIC: NCT03527992

BioSeek: NCT03527992

Cuvinte cheie

Abstract

Hypoxemic pneumonia is a major cause of hospitalization in Pulmonology. The patient's dependency on oxygen prevents early discharge from the hospital. 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. This system has proven to be particularly effective with chronic obstructive pulmonary disease (COPD) patients, by decreasing the time spent in hypoxia and hyperoxia, and by accelerating the weaning of oxygen. Our hypothesis is that automated oxygen therapy leads to a diminution on the length of hospital stay.

Descriere

Prolonged hospitalization has many consequences, including loss of autonomy and nosocomial infection. Moreover, these complications themselves lead to an extension of the length of stay. This has an impact on the cost of care: several studies have shown that hospitalization is the most costly factor in the management of pneumonia, and that even a small amount of hospital stay, led to significant financial savings. Automated oxygen therapy is a device that automatically adjusts with the saturation the amount of oxygen administered. Investigator hypothesis is that automated oxygen therapy could shorten the length of stay of patients hospitalized for hypoxemic pneumonia. One group of patients will receive the automated oxygen therapy and the other group will receive the standard Oxygen therapy. The investigator will compare in each group the average length of stay, the duration of oxygen therapy, the time spent outside of the target saturation, the cost on the medical-economic level and the patient's experience.

Datele

Ultima verificare:	06/30/2019
Primul depus:	03/07/2018
Inscriere estimată trimisă:	05/15/2018
Prima postare:	05/16/2018
Ultima actualizare trimisă:	07/10/2019
Ultima actualizare postată:	07/14/2019
Data actuală de începere a studiului:	03/08/2018
Data estimată de finalizare primară:	08/31/2021
Data estimată de finalizare a studiului:	08/31/2021

Stare sau boală

Pneumonia

Pneumonia, Ventilator-Associated

Length of Stay

Intervenție / tratament

Device: Automated oxygen therapy

Device: Standard Oxygen therapy

Fază

Grupuri de brațe

Braţ	Intervenție / tratament
Other: 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: Automated oxygen therapy 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.
Other: Standard Oxygen therapy Patients will receive O2 standard therapy	Device: Standard Oxygen therapy 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

Criterii de eligibilitate

Vârste eligibile pentru studiu	18 Years La 18 Years
Sexe eligibile pentru studiu	All
Acceptă voluntari sănătoși	da
Criterii	Inclusion Criteria: - Adult - Patient living at home or in an institution - Patient hospitalized for less than 48 hours - Pneumonia defined (according to the 2006 French-speaking infectious pneumology society (SPILF) criteria) by: - respiratory functional symptoms (cough, sputum, dyspnea, chest pain) and - Hyperthermia >38,5°C or hypothermia <36°C and - Radiological Signs of Pneumonia - Hypoxia : SpO2 < 94% in ambient air and/or PaO2< 60 mmHg in ambient air Exclusion Criteria: - Pneumonia acquired at the hospital. - Patient hospitalized in another department more than 48 hours before admission - Chronic respiratory failure - Active neoplasia - Patients undergoing oxygen therapy and / or long-term NIV - Associated cardiac decompensation (clinical signs and / or NTproBNP> 1800ng / mL) (3 - Initial Need for high flow oxygen therapy or ventilatory support (NIV, VI) - Difficulties expected from home support.

Rezultat

Măsuri de rezultate primare

1. Length in days of hospital stay [1 month]

measure of total days of hospitalization and intensive care

Măsuri de rezultate secundare

1. Duration of oxygen therapy [1 month]

Oxygen therapy time evaluation during hospitalization of patient

2. Time spent outside of the target saturation [1 month]

Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,

3. the cost on the medical-economic level [1 month]

investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"

4. rate of medical complication [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"

5. quality questionnaire of patient's life during hospitalization [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"

Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Cuvinte cheie

pneumonie

pleuropneumonia

hiperoxie

hypoxia