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NCT Number: NCT03527992

Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Larrey

Toulouse, 31049, France

Location status: Recruiting

Location contact

Alain Didier, MD

SUB_INVESTIGATOR

Elise Noel-Savina, MD

CONTACT

[email protected]

5 67 77 16 90 ext. 33

Elise Noel-Savina, MD

PRINCIPAL_INVESTIGATOR

Sandrine Pontier-Marchandise, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

O2 automated

Device

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 standard

Device

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 outcomes

  1. Length in days of hospital stay

    Time frame: 1 month

    measure of total days of hospitalization and intensive care

Secondary outcomes

  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"

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Noel-Savina, MD

CONTACT

[email protected]

5 67 77 16 90 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: OPPAÎ

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
May 17, 2018
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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