Back to resultsClosed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)
Primary Purpose
Coronavirus, Pneumonia, Oxygen Toxicity
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard administration of oxygen flow
Automated oxygen administration - FreeO2
Sponsored by
About this trial
This is an interventional other trial for Coronavirus
Eligibility 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
Sites / Locations
- Institut universitaire de cardiologie et de pneumologie de Québec - Université LavalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Intervention group
Arm Description
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
Usual care will be provide to patients concerning their medical management. In the Intervention group, automated oxygen administration will be delivered with FreeO2
Outcomes
Primary Outcome Measures
The number of interventions
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Duration of interventions
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Secondary Outcome Measures
Mean oxygen flow
The Mean oxygen flow during study duration to evaluate oxygen consumption
Time within theSpO2 target
Time within SpO2 between 90 and 94%
Time with hypoxemia
Time within SpO2 < 88%
Time with hyperoxemia
Time within SpO2 > 96%
Rate of ICU admission
Rate of ICU admission
Rate of needed non invasive respiratory support
Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Rate of intubation
Rate of intubation
NEWS 2 score evolution
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
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
Cost effectiveness ratio (cost per SpO2 unit)
length of stay
Duration of the hospital length of stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04320056
Brief Title
Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Pneumonia, Oxygen Toxicity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Usual care will be provide to patients concerning their medical management.
In the Intervention group, automated oxygen administration will be delivered with FreeO2
Intervention Type
Other
Intervention Name(s)
Standard administration of oxygen flow
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Automated oxygen administration - FreeO2
Intervention Description
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%)
Primary Outcome Measure Information:
Title
The number of interventions
Description
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Time Frame
Hour0 to Hour4
Title
Duration of interventions
Description
The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Time Frame
Hour0 to Hour24
Secondary Outcome Measure Information:
Title
Mean oxygen flow
Description
The Mean oxygen flow during study duration to evaluate oxygen consumption
Time Frame
Hour0 to Hour24 (1 day)
Title
Time within theSpO2 target
Description
Time within SpO2 between 90 and 94%
Time Frame
Hour0 to Hour24 (1 day)
Title
Time with hypoxemia
Description
Time within SpO2 < 88%
Time Frame
Hour0 to Hour24 (1 day)
Title
Time with hyperoxemia
Description
Time within SpO2 > 96%
Time Frame
Hour0 to Hour24 (1 day)
Title
Rate of ICU admission
Description
Rate of ICU admission
Time Frame
Hour0 to Hour24 (1 day)
Title
Rate of needed non invasive respiratory support
Description
Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Time Frame
Hour0 to Hour24 (1 day)
Title
Rate of intubation
Description
Rate of intubation
Time Frame
Hour0 to Hour24 (1 day)
Title
NEWS 2 score evolution
Description
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.
Time Frame
Hour0 to Hour24 (1 day)
Title
EWSO2 score evolution
Description
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.
Time Frame
Hour0 to Hour24 (1 day)
Title
Cost-effectiveness
Description
Cost effectiveness ratio (cost per SpO2 unit)
Time Frame
From date of randomization until the date of hospital discharge
Title
length of stay
Description
Duration of the hospital length of stay
Time Frame
up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François Lellouche
Phone
418-656-8711
Ext
3572
Email
francois.lellouche@criucpq.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Alexandre Bouchard
Phone
418-656-8711
Ext
2712
Email
pierre-alexandre.bouchard@criucpq.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Lellouche
Organizational Affiliation
IUCPQ-UL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Alexandre Bouchard
Phone
418-656-8711
Ext
2712
Email
pierre-alexandre.bouchard@criucpq.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Francois Lellouche
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
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https://www.nytimes.com/2020/02/06/world/asia/chinese-doctor-Li-Wenliang-coronavirus.html
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https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200205-sitrep-16-ncov.pdf?sfvrsn=23af287f_4
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https://www.who.int/emergencies/diseases/novel-coronavirus-2019
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https://www.who.int/docs/default-source/coronaviruse/20200205-hcw-protocol-2019-ncov-v1-2.pdf?sfvrsn=c8513be3_1&download=true
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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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