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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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 group | Experimental | Usual care will be provide to patients concerning their medical management. In the Intervention group, automated oxygen administration will be delivered with FreeO2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard administration of oxygen flow | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of interventions | The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours | Hour0 to Hour4 |
| Duration of interventions | The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours | Hour0 to Hour24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean oxygen flow | The Mean oxygen flow during study duration to evaluate oxygen consumption | Hour0 to Hour24 (1 day) |
| Time within theSpO2 target | Time within SpO2 between 90 and 94% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François Lellouche | Contact | 418-656-8711 | 3572 | francois.lellouche@criucpq.ulaval.ca |
| Pierre-Alexandre Bouchard | Contact | 418-656-8711 | 2712 | pierre-alexandre.bouchard@criucpq.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Francois Lellouche | IUCPQ-UL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval | Recruiting | Québec | G1V4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32031570 | Background | Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. | |
| 28177862 | Background |
| Label | URL |
|---|---|
| Related Info | View source |
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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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|
| Automated oxygen administration - FreeO2 | Device | 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%) |
|
| Hour0 to Hour24 (1 day) |
| Time with hypoxemia | Time within SpO2 < 88% | Hour0 to Hour24 (1 day) |
| Time with hyperoxemia | Time within SpO2 > 96% | Hour0 to Hour24 (1 day) |
| Rate of ICU admission | Rate of ICU admission | Hour0 to Hour24 (1 day) |
| Rate of needed non invasive respiratory support | Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy | Hour0 to Hour24 (1 day) |
| Rate of intubation | Rate of intubation | Hour0 to Hour24 (1 day) |
| 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. | Hour0 to Hour24 (1 day) |
| 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. | Hour0 to Hour24 (1 day) |
| Cost-effectiveness | Cost effectiveness ratio (cost per SpO2 unit) | From date of randomization until the date of hospital discharge |
| length of stay | Duration of the hospital length of stay | up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured |
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| Related Info | View source |
| Related Info | View source |
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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