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

NCT04320056 | Unknown

• 1 other identifier: 21909
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The number of interventions

  The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours

  Hour0 to Hour4

• Duration of interventions

  The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours

  Hour0 to Hour24

Secondary Outcomes (11)

• Mean oxygen flow

  Hour0 to Hour24 (1 day)

• Time within theSpO2 target

  Hour0 to Hour24 (1 day)

• Time with hypoxemia

  Hour0 to Hour24 (1 day)

• Time with hyperoxemia

  Hour0 to Hour24 (1 day)

• Rate of ICU admission

  Hour0 to Hour24 (1 day)

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Standard administration of oxygen flow

Intervention group

EXPERIMENTAL

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

Device: Automated oxygen administration - FreeO2

Interventions

Standard administration of oxygen flow OTHER

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

Control group

Automated oxygen administration - FreeO2 DEVICE

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%)

Intervention group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Withdrawal of life support or palliation as the goal of care
• patients' or next of kin refusal to participate to the study

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

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

Québec, G1V4G5, Canada

RECRUITING

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Related Links

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MeSH Terms

Conditions

Coronavirus Infections; Pneumonia

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Francois Lellouche

  IUCPQ-UL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Lellouche

CONTACT

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

Pierre-Alexandre Bouchard

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 24, 2020
• Study Start: April 20, 2020
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2021
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)