Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Pneumonia Clinical Trial

— OPPAÎ  

Official title:

Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03527992
• Other study ID #: RC31/17/0404
• Secondary ID: 2017-A03642-51
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Elise Noel-Savina, MD
• Phone: 5 67 77 16 90
• Email: noel-savina.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Length of Stay
• Pleuropneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated

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.
• 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

Locations

Country	Name	City	State
France	CHU Larrey	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length in days of hospital stay	measure of total days of hospitalization and intensive care	1 month
Secondary	Duration of oxygen therapy	Oxygen therapy time evaluation during hospitalization of patient	1 month
Secondary	Time spent outside of the target saturation	Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,	1 month
Secondary	the cost on the medical-economic level	investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"	1 month
Secondary	rate of medical complication	Investigator want to evaluate the rate of medical complication between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"	1 month
Secondary	quality questionnaire of patient's life during hospitalization	Investigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"	1 month