We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04320056
Recruitment Status : Unknown
Verified April 2020 by Laval University.
Recruitment status was:  Recruiting
First Posted : March 24, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Laval University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Coronavirus Pneumonia Oxygen Toxicity Other: Standard administration of oxygen flow Device: Automated oxygen administration - FreeO2 Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 20, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Mean oxygen flow [ Time Frame: Hour0 to Hour24 (1 day) ]
    The Mean oxygen flow during study duration to evaluate oxygen consumption

  2. Time within theSpO2 target [ Time Frame: Hour0 to Hour24 (1 day) ]
    Time within SpO2 between 90 and 94%

  3. Time with hypoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]
    Time within SpO2 < 88%

  4. Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]
    Time within SpO2 > 96%

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

  6. 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

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

  8. 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.


  9. 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.


  10. Cost-effectiveness [ Time Frame: From date of randomization until the date of hospital discharge ]
    Cost effectiveness ratio (cost per SpO2 unit)

  11. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320056


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval Recruiting
Quebec, Canada, G1V4G5
Contact: Pierre-Alexandre Bouchard    418-656-8711 ext 2712    pierre-alexandre.bouchard@criucpq.ulaval.ca   
Principal Investigator: Francois Lellouche         
Sponsors and Collaborators
Laval University
Investigators
Layout table for investigator information
Principal Investigator: Francois Lellouche IUCPQ-UL
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT04320056    
Other Study ID Numbers: 21909
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases