Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia (OPPAÎ)

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia; Pneumonia, Ventilator-Associated; Length of Stay
• Intervention / Treatment: Device: O2 automated; Device: O2 standard

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elise Noel-Savina, MD; Phone Number: 33 5 67 77 16 90; Email: noel-savina.e@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31049
    • Recruiting
    • CHU Larrey
    • Principal Investigator: Elise NOEL-SAVINA, MD
    • Sub-Investigator: Alain Didier, MD
    • Sub-Investigator: Sandrine Pontier-Marchandise, MD
    • Contact: Elise Noel-Savina, MD; Phone Number: 33 5 67 77 16 90; Email: noel-savina.e@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length in days of hospital stay	measure of total days of hospitalization and intensive care	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of oxygen therapy	Oxygen therapy time evaluation during hospitalization of patient	1 month
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Elise Noel-Savina, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2018
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: March 8, 2018
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (Actual): May 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 10, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Length of stay; Randomized Therapeutic trial; Hypoxemic pneumonia; Automated oxygen therapy; medico-economic cost
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Pleural Diseases; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pleurisy; Pneumonia; Pneumonia, Ventilator-Associated; Pleuropneumonia
• Other Study ID Numbers: RC31/17/0404; 2017-A03642-51 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No