Coronavirus, Oxygen Toxicity, Pneumonia
Conditions
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.
Interventions
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
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%)
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time with hypoxemia | Hour0 to Hour24 (1 day) | Time within SpO2 \< 88% |
| Time with hyperoxemia | Hour0 to Hour24 (1 day) | Time within SpO2 \> 96% |
| Rate of ICU admission | Hour0 to Hour24 (1 day) | Rate of ICU admission |
| 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 |
| Mean oxygen flow | Hour0 to Hour24 (1 day) | The Mean oxygen flow during study duration to evaluate oxygen consumption |
| 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. |
| 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. |
| 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 |
| Rate of intubation | Hour0 to Hour24 (1 day) | Rate of intubation |
| Time within theSpO2 target | Hour0 to Hour24 (1 day) | Time within SpO2 between 90 and 94% |
Countries
Canada
Contacts
Primary ContactFrançois Lellouche
Backup ContactPierre-Alexandre Bouchard
Outcome results
None listed