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Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03527992
Acronym
OPPAÎ
Enrollment
59
Registered
2018-05-17
Start date
2018-03-09
Completion date
2024-10-03
Last updated
2026-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length of Stay, Pneumonia, Pneumonia, Ventilator-Associated

Keywords

Randomized Therapeutic trial, Hypoxemic pneumonia, Automated oxygen therapy, Length of stay, medico-economic cost

Brief summary

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.

Detailed description

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.

Interventions

DEVICEO2 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.

DEVICEO2 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

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Length in days of hospital stay1 monthmeasure of total days of hospitalization and intensive care

Secondary

MeasureTime frameDescription
Duration of oxygen therapy1 monthOxygen therapy time evaluation during hospitalization of patient
Time spent outside of the target saturation1 monthInvestigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,
the cost on the medical-economic level1 monthinvestigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
rate of medical complication1 monthInvestigator 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 hospitalization1 monthInvestigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"

Countries

France

Contacts

PRINCIPAL_INVESTIGATORElise Noel-Savina, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 12, 2026