Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)

Laval University

Status: Unknown

Conditions: Oxygen Toxicity; Pneumonia; Coronavirus

Treatments: Device: Automated oxygen administration - FreeO2; Other: Standard administration of oxygen flow

Study type: Interventional

Funder types: Other

Identifiers

NCT04320056

21909

Details and patient eligibility

About

There is a high risk of transmission of COVID-19 to healthcare workers. In a recent cohort, 29% of the patients hospitalized were healthcare workers. Among the WHO's primary strategic objectives for the response to COVID-19, the first was to limit human-to-human transmission, including reducing secondary infections among close contacts and health care workers.

Automated oxygen titration, weaning and monitoring (FreeO2 device) may be a solution to reduce the number of interventions of healthcare workers related to oxygen therapy, to reduce complications related to oxygen and to improve monitoring.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age> 18 years old
• patients with acute respiratory failure related to suspected community acquired pneumonia (viral and non viral) requiring oxygen therapy < 6 L/min (or FiO2< 0.50) (to maintain SpO2 between 90 and 94% SpO2) without criteria for immediate intubation or ICU transfer.
• Patients hospital admission < 72 hours

Exclusion criteria

• shock state,
• no SpO2 signal available,
• patient agitation,
• pH < 7.30 (if blood gas available)
• PaCO2 > 50 mmHg, (if blood gas available) or chronic hypercapnia history
• Non invasive respiratory support (NIV, High flow Nasal Therapy (HFNT)) at study inclusion
• Withdrawal of life support or palliation as the goal of care
• patients' or next of kin refusal to participate to the study

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Control group

Active Comparator group

Description:

Usual care will be provide to patients concerning their medical management. In the Control Group usual, oxygen will be delivered as per usual local practices

Treatment:

Other: Standard administration of oxygen flow

Intervention group

Experimental group

Description:

Usual care will be provide to patients concerning their medical management. In the Intervention group, automated oxygen administration will be delivered with FreeO2

Treatment:

Device: Automated oxygen administration - FreeO2