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

Toulouse University Hospital

Status: Enrolling

Conditions: Length of Stay; Pneumonia, Ventilator-Associated; Pneumonia

Treatments: Device: O2 standard; Device: O2 automated

Study type: Interventional

Funder types: Other

Identifiers

NCT03527992

2017-A03642-51 (Other Identifier)

RC31/17/0404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Automated oxygen therapy

Other group

Description:

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.

Treatment:

Device: O2 automated

Standard Oxygen therapy

Other group

Description:

Patients will receive O2 standard therapy

Treatment:

Device: O2 standard