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

Not Applicable
Conditions
Coronavirus
Oxygen Toxicity
Pneumonia
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

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
Primary Outcome Measures
NameTimeMethod
The number of interventionsHour0 to Hour4

The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours

Duration of interventionsHour0 to Hour24

The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours

Secondary Outcome Measures
NameTimeMethod
Time with hyperoxemiaHour0 to Hour24 (1 day)

Time within SpO2 \> 96%

Time with hypoxemiaHour0 to Hour24 (1 day)

Time within SpO2 \< 88%

Mean oxygen flowHour0 to Hour24 (1 day)

The Mean oxygen flow during study duration to evaluate oxygen consumption

Rate of needed non invasive respiratory supportHour0 to Hour24 (1 day)

Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy

Cost-effectivenessFrom date of randomization until the date of hospital discharge

Cost effectiveness ratio (cost per SpO2 unit)

length of stayup 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 evolutionHour0 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.

Time within theSpO2 targetHour0 to Hour24 (1 day)

Time within SpO2 between 90 and 94%

Rate of ICU admissionHour0 to Hour24 (1 day)

Rate of ICU admission

Rate of intubationHour0 to Hour24 (1 day)

Rate of intubation

EWSO2 score evolutionHour0 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.

Trial Locations

Locations (1)

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

🇨🇦

Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
🇨🇦Quebec, Canada
Pierre-Alexandre Bouchard
Contact
418-656-8711
pierre-alexandre.bouchard@criucpq.ulaval.ca
Francois Lellouche
Principal Investigator

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