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

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ClinicalTrials.gov Identifier: NCT04320056
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Laval University

Tracking Information
First Submitted Date  ICMJE March 19, 2020
First Posted Date  ICMJE March 24, 2020
Last Update Posted Date April 21, 2020
Actual Study Start Date  ICMJE April 20, 2020
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2020)
  • Mean oxygen flow [ Time Frame: Hour0 to Hour24 (1 day) ]
    The Mean oxygen flow during study duration to evaluate oxygen consumption
  • Time within theSpO2 target [ Time Frame: Hour0 to Hour24 (1 day) ]
    Time within SpO2 between 90 and 94%
  • Time with hypoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]
    Time within SpO2 < 88%
  • Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]
    Time within SpO2 > 96%
  • Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]
    Rate of ICU admission
  • 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
  • Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]
    Rate of intubation
  • 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.
  • 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.
  • Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]
    Cost effectiveness ratio (cost per SpO2 unit)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)
Official Title  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Coronavirus
  • Pneumonia
  • Oxygen Toxicity
Intervention  ICMJE
  • 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

  • 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%)
Study Arms  ICMJE
  • 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

    Intervention: Other: Standard administration of oxygen flow
  • 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

    Intervention: Device: Automated oxygen administration - FreeO2
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2020)
216
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: François Lellouche 418-656-8711 ext 3572 francois.lellouche@criucpq.ulaval.ca
Contact: Pierre-Alexandre Bouchard 418-656-8711 ext 2712 pierre-alexandre.bouchard@criucpq.ulaval.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04320056
Other Study ID Numbers  ICMJE 21909
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party Laval University
Study Sponsor  ICMJE Laval University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francois Lellouche IUCPQ-UL
PRS Account Laval University
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP