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

Sponsor
Laval University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04320056
Collaborator
(none)
216
1
2
18.4
11.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard administration of oxygen flow
  • Device: Automated oxygen administration - FreeO2
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
216 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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)
Actual Study Start Date :
Apr 20, 2020
Anticipated Primary Completion Date :
Apr 30, 2021
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

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%)

Outcome Measures

Primary Outcome Measures

  1. The number of interventions [Hour0 to Hour4]

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

  2. Duration of interventions [Hour0 to Hour24]

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

Secondary Outcome Measures

  1. Mean oxygen flow [Hour0 to Hour24 (1 day)]

    The Mean oxygen flow during study duration to evaluate oxygen consumption

  2. Time within theSpO2 target [Hour0 to Hour24 (1 day)]

    Time within SpO2 between 90 and 94%

  3. Time with hypoxemia [Hour0 to Hour24 (1 day)]

    Time within SpO2 < 88%

  4. Time with hyperoxemia [Hour0 to Hour24 (1 day)]

    Time within SpO2 > 96%

  5. Rate of ICU admission [Hour0 to Hour24 (1 day)]

    Rate of ICU admission

  6. Rate of needed non invasive respiratory support [Hour0 to Hour24 (1 day)]

    Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy

  7. Rate of intubation [Hour0 to Hour24 (1 day)]

    Rate of intubation

  8. NEWS 2 score evolution [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.

  9. EWSO2 score evolution [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.

  10. Cost-effectiveness [From date of randomization until the date of hospital discharge]

    Cost effectiveness ratio (cost per SpO2 unit)

  11. length of stay [up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured]

    Duration of the hospital length of stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Quebec Canada G1V4G5

Sponsors and Collaborators

  • Laval University

Investigators

  • Principal Investigator: Francois Lellouche, IUCPQ-UL

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Laval University
ClinicalTrials.gov Identifier:
NCT04320056
Other Study ID Numbers:
  • 21909
First Posted:
Mar 24, 2020
Last Update Posted:
Apr 21, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2020