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

Primary Purpose

Pneumonia, Pneumonia, Ventilator-Associated, Length of Stay

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
O2 automated
O2 standard
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Randomized Therapeutic trial, Hypoxemic pneumonia, Automated oxygen therapy, Length of stay, medico-economic cost

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • CHU LarreyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Automated oxygen therapy

Standard Oxygen therapy

Arm 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.

Patients will receive O2 standard therapy

Outcomes

Primary Outcome Measures

Length in days of hospital stay
measure of total days of hospitalization and intensive care

Secondary Outcome Measures

Duration of oxygen therapy
Oxygen therapy time evaluation during hospitalization of patient
Time spent outside of the target saturation
Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,
the cost on the medical-economic level
investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
rate of medical complication
Investigator want to evaluate the rate of medical complication between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
quality questionnaire of patient's life during hospitalization
Investigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"

Full Information

First Posted
March 8, 2018
Last Updated
July 10, 2023
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03527992
Brief Title
Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
Acronym
OPPAÎ
Official Title
Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumonia, Ventilator-Associated, Length of Stay
Keywords
Randomized Therapeutic trial, Hypoxemic pneumonia, Automated oxygen therapy, Length of stay, medico-economic cost

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Automated oxygen therapy
Arm Type
Other
Arm 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.
Arm Title
Standard Oxygen therapy
Arm Type
Other
Arm Description
Patients will receive O2 standard therapy
Intervention Type
Device
Intervention Name(s)
O2 automated
Intervention Description
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
Intervention Name(s)
O2 standard
Intervention Description
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 Measure Information:
Title
Length in days of hospital stay
Description
measure of total days of hospitalization and intensive care
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Duration of oxygen therapy
Description
Oxygen therapy time evaluation during hospitalization of patient
Time Frame
1 month
Title
Time spent outside of the target saturation
Description
Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,
Time Frame
1 month
Title
the cost on the medical-economic level
Description
investigator want evaluate the cost of hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
Time Frame
1 month
Title
rate of medical complication
Description
Investigator want to evaluate the rate of medical complication between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
Time Frame
1 month
Title
quality questionnaire of patient's life during hospitalization
Description
Investigator want to evaluate the quality of life during hospitalization between patient in arm "Automated oxygen therapy" and patient in arm "Standard Oxygen therapy"
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Noel-Savina, MD
Phone
5 67 77 16 90
Ext
33
Email
noel-savina.e@chu-toulouse.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elise Noel-Savina, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Larrey
City
Toulouse
ZIP/Postal Code
31049
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Noel-Savina, MD
Phone
5 67 77 16 90
Ext
33
Email
noel-savina.e@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Elise Noel-Savina, MD
First Name & Middle Initial & Last Name & Degree
Sandrine Pontier-Marchandise, MD
First Name & Middle Initial & Last Name & Degree
Alain Didier, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

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