OPPAÎ: Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT03527992
Collaborator
(none)
128
1
2
54.8
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: O2 automated
  • Device: O2 standard
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
Actual Study Start Date :
Mar 9, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Length in days of hospital stay [1 month]

    measure of total days of hospitalization and intensive care

Secondary Outcome Measures

  1. Duration of oxygen therapy [1 month]

    Oxygen therapy time evaluation during hospitalization of patient

  2. Time spent outside of the target saturation [1 month]

    Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,

  3. the cost on the medical-economic level [1 month]

    investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"

  4. rate of medical complication [1 month]

    Investigator want to evaluate the rate of medical complication between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"

  5. quality questionnaire of patient's life during hospitalization [1 month]

    Investigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Larrey Toulouse France 31049

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT03527992
Other Study ID Numbers:
  • RC31/17/0404
  • 2017-A03642-51
First Posted:
May 17, 2018
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Toulouse
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022