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

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ClinicalTrials.gov Identifier: NCT03527992
Recruitment Status : Recruiting
First Posted : May 17, 2018
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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
Pneumonia Pneumonia, Ventilator-Associated Length of Stay Device: O2 automated Device: O2 standard Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 9, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. Length in days of hospital stay [ Time Frame: 1 month ]
    measure of total days of hospitalization and intensive care


Secondary Outcome Measures :
  1. Duration of oxygen therapy [ Time Frame: 1 month ]
    Oxygen therapy time evaluation during hospitalization of patient

  2. Time spent outside of the target saturation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527992


Contacts
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Contact: Elise Noel-Savina, MD 5 67 77 16 90 ext 33 noel-savina.e@chu-toulouse.fr

Locations
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France
CHU Larrey Recruiting
Toulouse, France, 31049
Contact: Elise Noel-Savina, MD    5 67 77 16 90 ext 33    noel-savina.e@chu-toulouse.fr   
Principal Investigator: Elise Noel-Savina, MD         
Sub-Investigator: Sandrine Pontier-Marchandise, MD         
Sub-Investigator: Alain Didier, MD         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Elise Noel-Savina, MD University Hospital, Toulouse
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03527992    
Other Study ID Numbers: RC31/17/0404
2017-A03642-51 ( Other Identifier: ID-RCB )
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Randomized Therapeutic trial
Hypoxemic pneumonia
Automated oxygen therapy
Length of stay
medico-economic cost
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Pleuropneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Pleurisy
Pleural Diseases