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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04320056
Other study ID # 21909
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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L'Her E, Dias P, Gouillou M, Riou A, Souquiere L, Paleiron N, Archambault P, Bouchard PA, Lellouche F. Automatic versus manual oxygen administration in the emergency department. Eur Respir J. 2017 Jul 20;50(1). pii: 1602552. doi: 10.1183/13993003.02552-2016. Print 2017 Jul. — View Citation

L'her E, Jaber S, Verzilli D, Jacob C, Huiban B, Futier E, Kerforne T, Pateau V, Bouchard PA, Gouillou M, Nowak E, Lellouche F. Automated oxygen administration versus conventional oxygen therapy after major abdominal or thoracic surgery: study protocol for an international multicentre randomised controlled study. BMJ Open. 2019 Jan 17;9(1):e023833. doi: 10.1136/bmjopen-2018-023833. — View Citation

L'Her E, N'Guyen QT, Pateau V, Bodenes L, Lellouche F. Photoplethysmographic determination of the respiratory rate in acutely ill patients: validation of a new algorithm and implementation into a biomedical device. Ann Intensive Care. 2019 Jan 21;9(1):11. doi: 10.1186/s13613-019-0485-z. — View Citation

Lellouche F, Bouchard PA, Roberge M, Simard S, L'Her E, Maltais F, Lacasse Y. Automated oxygen titration and weaning with FreeO2 in patients with acute exacerbation of COPD: a pilot randomized trial. Int J Chron Obstruct Pulmon Dis. 2016 Aug 24;11:1983-90. doi: 10.2147/COPD.S112820. eCollection 2016. — View Citation

Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. Epub 2016 Oct 18. — View Citation

Lellouche F, L'her E. Automated oxygen flow titration to maintain constant oxygenation. Respir Care. 2012 Aug;57(8):1254-62. doi: 10.4187/respcare.01343. Epub 2012 Feb 17. — View Citation

Lellouche F, L'Her E. Hyperoxemia: The Poison Is in the Dose. Am J Respir Crit Care Med. 2020 Feb 15;201(4):498. doi: 10.1164/rccm.201910-1898LE. — View Citation

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Poder TG, Kouakou CRC, Bouchard PA, Tremblay V, Blais S, Maltais F, Lellouche F. Cost-effectiveness of FreeO(2) in patients with chronic obstructive pulmonary disease hospitalised for acute exacerbations: analysis of a pilot study in Quebec. BMJ Open. 2018 Jan 23;8(1):e018835. doi: 10.1136/bmjopen-2017-018835. — View Citation

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* Note: There are 54 references in allClick 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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