Automated Oxygen Administration in Patients With Hypoxemic Pneumonia and Pleuropneumonia

NCT03527992 | Recruiting

• 2 other identifiers: RC31/17/04042017-A03642-51
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Pneumonia, Ventilator-Associated; Length of Stay

Keywords

Randomized Therapeutic trial; Hypoxemic pneumonia; Automated oxygen therapy; Length of stay; medico-economic cost

Outcome Measures

Primary Outcomes (1)

• Length in days of hospital stay

  measure of total days of hospitalization and intensive care

  1 month

Secondary Outcomes (5)

• Duration of oxygen therapy

  1 month

• Time spent outside of the target saturation

  1 month

• the cost on the medical-economic level

  1 month

• rate of medical complication

  1 month

• quality questionnaire of patient's life during hospitalization

  1 month

Study Arms (2)

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.

Device: O2 automated

Standard Oxygen therapy

OTHER

Patients will receive O2 standard therapy

Device: O2 standard

Interventions

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.

Automated oxygen therapy

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

Standard Oxygen therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Larrey

Toulouse, 31049, France

RECRUITING

MeSH Terms

Conditions

Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Healthcare-Associated Pneumonia; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elise Noel-Savina, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise Noel-Savina, MD

CONTACT

5 67 77 16 90; noel-savina.e@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: May 17, 2018
• Study Start: March 9, 2018
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)