Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

NCT ID: NCT03527992

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-09
• Study Completion Date: 2028-10-31

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.

Conditions

Pneumonia; Pneumonia, Ventilator-Associated; Length of Stay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

O2 automated

Intervention Type: DEVICE

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

Group Type: OTHER

O2 standard

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elise Noel-Savina, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Larrey

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Elise Noel-Savina, MD

Role: CONTACT

noel-savina.e@chu-toulouse.fr

5 67 77 16 90 ext. 33

Facility Contacts

Elise Noel-Savina, MD

Role: primary

noel-savina.e@chu-toulouse.fr

5 67 77 16 90 ext. 33

Other Identifiers

2017-A03642-51

Identifier Type: OTHER

Identifier Source: secondary_id

RC31/17/0404

Identifier Type: -

Identifier Source: org_study_id