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

April 20, 2020 updated by: Laval University

Automated Oxygen Titration - Monitoring and Weaning in Patients With Infectious Pneumonia Requiring Oxygen - Impact on the Number of Interventions for Healthcare Workers. An Innovative Device to Manage Patients With COVID-19 Pneumonia COVID Study (Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decreaseduring Pneumonia)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V4G5
        • Recruiting
        • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: 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
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
Device: 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%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of interventions
Time Frame: Hour0 to Hour4
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
Time Frame: Hour0 to Hour24
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Hour0 to Hour24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean oxygen flow
Time Frame: Hour0 to Hour24 (1 day)
The Mean oxygen flow during study duration to evaluate oxygen consumption
Hour0 to Hour24 (1 day)
Time within theSpO2 target
Time Frame: Hour0 to Hour24 (1 day)
Time within SpO2 between 90 and 94%
Hour0 to Hour24 (1 day)
Time with hypoxemia
Time Frame: Hour0 to Hour24 (1 day)
Time within SpO2 < 88%
Hour0 to Hour24 (1 day)
Time with hyperoxemia
Time Frame: Hour0 to Hour24 (1 day)
Time within SpO2 > 96%
Hour0 to Hour24 (1 day)
Rate of ICU admission
Time Frame: Hour0 to Hour24 (1 day)
Rate of ICU admission
Hour0 to Hour24 (1 day)
Rate of needed non invasive respiratory support
Time Frame: Hour0 to Hour24 (1 day)
Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Hour0 to Hour24 (1 day)
Rate of intubation
Time Frame: Hour0 to Hour24 (1 day)
Rate of intubation
Hour0 to Hour24 (1 day)
NEWS 2 score evolution
Time Frame: Hour0 to Hour24 (1 day)

Evaluation of NEWS 2 score evolution (National Early Warning score) correlate to patient evolution.

The NEWS2 score will be calculate but no intervention will be made based on this score.

Patient evolution will be compare at NEWS 2 interpretation.

Interpretation A low score (NEWS 1-4) should prompt assessment by a competent registered nurse who should decide if a change to frequency of clinical monitoring or an escalation of clinical care is required.

A medium score (ie NEWS of 5-6 or a RED score) should consider whether escalation of care to a team with critical-care skills is required (ie critical care outreach team).

A high score (NEWS ≥7) should prompt emergency assessment by a clinical team/critical care outreach team with critical-care competencies and usually transfer of the patient to a higher dependency care area.
Hour0 to Hour24 (1 day)
EWSO2 score evolution
Time Frame: Hour0 to Hour24 (1 day)

Evaluation of EWSO2 score(Early Warning ScoreO2) evolution correlate to patient evolution

The EWSO2 score will be calculate but no intervention will be made based on this score.

Patient evolution will be compare at EWSO2 interpretation.

Interpretation Favorable clinical outcome in patients with a score <5.3 A patient with a score >18.6 will experience a poor outcome.
Hour0 to Hour24 (1 day)
Cost-effectiveness
Time Frame: From date of randomization until the date of hospital discharge
Cost effectiveness ratio (cost per SpO2 unit)
From date of randomization until the date of hospital discharge
length of stay
Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured
Duration of the hospital length of stay
up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Principal Investigator: Francois Lellouche, IUCPQ-UL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2020

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

October 31, 2021

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 21, 2020

Last Update Submitted That Met QC Criteria

April 20, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21909

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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