PneumoniaOPPAÎNCT03527992
Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
A study testing O2 automated and O2 standard in people with Pneumonia and Pneumonia, Ventilator-Associated, run by University Hospital, Toulouse at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Pneumonia, Ventilator-Associated, Length of Stay
- What is being tested?
- O2 automated and O2 standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2018to 3 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pneumonia, Pneumonia, Ventilator-Associated, Length of Stay
- Being tested
- O2 automated, O2 standard
- Keywords
- Randomized Therapeutic trial, Hypoxemic pneumonia, Automated oxygen therapy, Length of stay, medico-economic cost
- Medical subject headings
- Pneumonia, Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O2 automatedDevice
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.
O2 standardDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Automated oxygen therapy | Other | 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. Receives: Device: O2 automated |
| Standard Oxygen therapy | Other | Patients will receive O2 standard therapy Receives: Device: O2 standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length in days of hospital stay
measure of total days of hospitalization and intensive care
Measured: 1 month
Secondary outcomes (5)
Duration of oxygen therapy
Oxygen therapy time evaluation during hospitalization of patient
Measured: 1 month
Time spent outside of the target saturation
Investigator want evaluate the time spent outside of the target saturation by patient, during their hospitalization,
Measured: 1 month
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"
Measured: 1 month
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"
Measured: 1 month
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"
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start9 Mar 2018
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise Noel-Savina, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527992
- Sponsor's protocol ID
- RC31/17/0404
- Other IDs
- 2017-A03642-51
- Acronym
- OPPAÎ
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2018
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia
- ClinicalTrials.gov ID
- NCT03527992
- Acronym / sponsor ID
- OPPAÎ / RC31/17/0404
- Conditions
- Pneumonia, Pneumonia, Ventilator-Associated, Length of Stay
- Keywords
- Randomized Therapeutic trial, Hypoxemic pneumonia, Automated oxygen therapy, Length of stay, medico-economic cost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated oxygen therapy | Other | Device: O2 automatedAn 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. |
| Standard Oxygen therapy | Other | Device: O2 standardPatients will receive O2 standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Hypoxia : SpO2 < 94% in ambient air and/or PaO2< 60 mmHg in ambient air
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O2 automatedIn 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. | Device | Automated oxygen therapy |
| O2 standardIn 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 | Device | Standard Oxygen therapy |
Primary outcome
Length in days of hospital stay
Time frame: 1 month
measure of total days of hospitalization and intensive care
5 secondary outcomes
Duration of oxygen therapy
Time frame: 1 month
Time spent outside of the target saturation
Time frame: 1 month
the cost on the medical-economic level
Time frame: 1 month
rate of medical complication
Time frame: 1 month
quality questionnaire of patient's life during hospitalization
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elise Noel-Savina, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O2 automated and O2 standard in people with Pneumonia and Pneumonia, Ventilator-Associated, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length in days of hospital stay (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.