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

Not Applicable

• Conditions: Coronavirus; Oxygen Toxicity; Pneumonia
• Interventions: Other: Standard administration of oxygen flow; Device: Automated oxygen administration - FreeO2

• Registration Number: NCT04320056
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Status Verified: 2020-04
• Study Start: 2020-04-20
• Last Update Submitted: 2020-04-20
• Last Update Posted: 2020-04-21
• Primary Completion: 2021-04-30
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standard administration of oxygen flow	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	Automated oxygen administration - FreeO2	Usual care will be provide to patients concerning their medical management. In the Intervention group, automated oxygen administration will be delivered with FreeO2

Primary Outcome Measures

Name	Time	Method
The number of interventions	Hour0 to Hour4	The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
Duration of interventions	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

Name	Time	Method
Time with hyperoxemia	Hour0 to Hour24 (1 day)	Time within SpO2 \> 96%
Time within theSpO2 target	Hour0 to Hour24 (1 day)	Time within SpO2 between 90 and 94%
Rate of ICU admission	Hour0 to Hour24 (1 day)	Rate of ICU admission
Rate of intubation	Hour0 to Hour24 (1 day)	Rate of intubation
Time with hypoxemia	Hour0 to Hour24 (1 day)	Time within SpO2 \< 88%
EWSO2 score evolution	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.
Mean oxygen flow	Hour0 to Hour24 (1 day)	The Mean oxygen flow during study duration to evaluate oxygen consumption
Rate of needed non invasive respiratory support	Hour0 to Hour24 (1 day)	Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
Cost-effectiveness	From date of randomization until the date of hospital discharge	Cost effectiveness ratio (cost per SpO2 unit)
length of stay	up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured	Duration of the hospital length of stay
NEWS 2 score evolution	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.

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; 🇨🇦 Quebec, Canada