Clinical trial NCT03527992: Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
Official title: Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumonia
Pneumonia, Ventilator-Associated
Length of Stay
Keywords: Randomized Therapeutic trial
Hypoxemic pneumonia
Automated oxygen therapy
Length of stay
medico-economic cost
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Length in days of hospital stay
timeFrame: 1 month
Secondary outcomes:
measure: Duration of oxygen therapy
timeFrame: 1 month
measure: Time spent outside of the target saturation
timeFrame: 1 month
measure: the cost on the medical-economic level
timeFrame: 1 month
measure: rate of medical complication
timeFrame: 1 month
measure: quality questionnaire of patient's life during hospitalization
timeFrame: 1 month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Larrey
Study officials:
affiliation: University Hospital, Toulouse
name: Elise Noel-Savina, MD
role: PRINCIPAL_INVESTIGATOR
References: