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

Pneumonia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320056
• Other study ID #: 21909
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2020
• Source: Laval University
• Contact: François Lellouche
• Phone: 418-656-8711
• Email: francois.lellouche[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: October 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus
• Oxygen Toxicity
• Pneumonia

Intervention

Other:
• 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

Device:
• 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%)

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

References & Publications (54)

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean oxygen flow	The Mean oxygen flow during study duration to evaluate oxygen consumption	Hour0 to Hour24 (1 day)
Secondary	Time within theSpO2 target	Time within SpO2 between 90 and 94%	Hour0 to Hour24 (1 day)
Secondary	Time with hypoxemia	Time within SpO2 < 88%	Hour0 to Hour24 (1 day)
Secondary	Time with hyperoxemia	Time within SpO2 > 96%	Hour0 to Hour24 (1 day)
Secondary	Rate of ICU admission	Rate of ICU admission	Hour0 to Hour24 (1 day)
Secondary	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)
Secondary	Rate of intubation	Rate of intubation	Hour0 to Hour24 (1 day)
Secondary	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)
Secondary	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)
Secondary	Cost-effectiveness	Cost effectiveness ratio (cost per SpO2 unit)	From date of randomization until the date of hospital discharge
Secondary	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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