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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Pneumonia, Coronavirus, Oxygen Toxicity

Intervention / Treatment
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* Other: Standard administration of oxygen flow
* Device: Automated oxygen administration - FreeO2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* 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<br>|
| Experimental: Intervention group<br>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<br>* 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%)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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% | 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 |