Recruiting

FreeO2

Sponsor:

Laval University

Code:

NCT04320056

Conditions

Coronavirus

Pneumonia

Oxygen Toxicity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Standard administration of oxygen flow

Automated oxygen administration - FreeO2

Study Details

Brief summary:

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.

Conditions

Coronavirus

Pneumonia

Oxygen Toxicity

Study ID

NCT04320056

Start date

Apr 20, 2020

Status verified date

Apr, 2020

Completion date

Oct 31, 2021

Anticipated

Primary completion date

Apr 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Control group

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

experimental: Intervention group

Usual care will be provide to patients concerning their medical management.

In the Intervention group, automated oxygen administration will be delivered with FreeO2

Interventions

Standard administration of oxygen flow

The investigator recommended SpO2 target of 90-94%. The investigator will recommend that low/high SpO2 alarms be set at 88% and 96% if continuous oximetry is used.

In this group the SpO2 was recorded any time with FreeO2 device - recording mode

Automated oxygen administration - FreeO2

In this group, oxygen administration will be delivered with FreeO2 (automated oxygen titration) with SpO2 target set at 92% (to maintain oxygenation in the recommended SpO2 target: 90-94%)

Primary outcome measure

  • The number of interventions [ Time Frame: Hour0 to Hour4 ]
  • Duration of interventions [ Time Frame: Hour0 to Hour24 ]

Central Contacts and Locations

Central contacts

François Lellouche

418-656-8711francois.lellouche@criucpq.ulaval.ca

Pierre-Alexandre Bouchard

418-656-8711pierre-alexandre.bouchard@criucpq.ulaval.ca

Locations

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Recruiting

Quebec, Canada, G1V4G5

Contacts

Pierre-Alexandre Bouchard

418-656-8711pierre-alexandre.bouchard@criucpq.ulaval.ca

Principal Investigator:

Francois Lellouche

More Information

Sponsor

Laval University

Last update posted

Apr 21, 2020

Last verified

Apr, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2020-04-21.