Closed-Loop Oxygen to Verify That Healthcare Workers Interventions Decrease During SARS-CoV-2 Pneumonia (COVID-19)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04320056|
Recruitment Status : Unknown
Verified April 2020 by Laval University.
Recruitment status was: Recruiting
First Posted : March 24, 2020
Last Update Posted : April 21, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronavirus Pneumonia Oxygen Toxicity||Other: Standard administration of oxygen flow Device: Automated oxygen administration - FreeO2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||216 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Active Comparator: Control group
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
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
Experimental: Intervention group
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
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%)
- The number of interventions [ Time Frame: 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 [ Time Frame: Hour0 to Hour24 ]The number of interventions required by healthcare workers to manage oxygen therapy (titration, weaning and monitoring) during 4 hours
- Mean oxygen flow [ Time Frame: Hour0 to Hour24 (1 day) ]The Mean oxygen flow during study duration to evaluate oxygen consumption
- Time within theSpO2 target [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 between 90 and 94%
- Time with hypoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 < 88%
- Time with hyperoxemia [ Time Frame: Hour0 to Hour24 (1 day) ]Time within SpO2 > 96%
- Rate of ICU admission [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of ICU admission
- Rate of needed non invasive respiratory support [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of needed non invasive respiratory support Non invasive ventilation or High Flow Nasal Therapy
- Rate of intubation [ Time Frame: Hour0 to Hour24 (1 day) ]Rate of intubation
- NEWS 2 score evolution [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From date of randomization until the date of hospital discharge ]Cost effectiveness ratio (cost per SpO2 unit)
- length of stay [ Time Frame: up to 90 days. Hospital stay - hospital admission through hospital discharge or until death if occured ]Duration of the hospital length of stay
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320056
|Contact: François Lellouche||418-656-8711 ext email@example.com|
|Contact: Pierre-Alexandre Bouchard||418-656-8711 ext firstname.lastname@example.org|
|Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval||Recruiting|
|Quebec, Canada, G1V4G5|
|Contact: Pierre-Alexandre Bouchard 418-656-8711 ext 2712 email@example.com|
|Principal Investigator: Francois Lellouche|
|Principal Investigator:||Francois Lellouche||IUCPQ-UL|
|Responsible Party:||Laval University|
|Other Study ID Numbers:||
|First Posted:||March 24, 2020 Key Record Dates|
|Last Update Posted:||April 21, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||No There is not plan to share individual participant data. All data if shared with be de-identified. Data will be stored on a secure server with access only by study personal.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Tract Infections
Respiratory Tract Diseases