Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)
NCT ID: NCT04320056
Last Updated: 2020-04-21
Study Results
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Basic Information
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UNKNOWN
NA
216 participants
INTERVENTIONAL
2020-04-20
2021-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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
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
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
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%)
Interventions
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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
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%)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Laval University
OTHER
Responsible Party
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Principal Investigators
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Francois Lellouche
Role: PRINCIPAL_INVESTIGATOR
IUCPQ-UL
Locations
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Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Other Identifiers
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21909
Identifier Type: -
Identifier Source: org_study_id
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