Interest in the Use of Nasal High-Flow Oxygen Therapy (OptiFlow™) in Secondary Transport of COVID-19 Positive Patients (SAMU83)

October 12, 2022 updated by: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Since the beginning of COVID-19 pandemic situation, several modes of ventilation have been tried to correct the hypoxaemia induced by SARS-CoV-2 virus. A few recent studies have concluded that high-flow nasal oxygen therapy (OptiFlow™) is beneficial in COVID-19. All mainly conclude that the use of OptiFlow™ avoid intubations and decrease hospitalization duration in critical care services.

At the emergency medical service 83 (SAMU 83), it has been decided to extend this ventilation mode during patient secondary transfers (transfer from an intensive care unit/other hospital unit/emergency department to another hospital's intensive care unit).

The emergency medical service 83 has equipped its intensive-care ambulances with OptiFlow™ in order not to interrupt this ventilation mode during transport.

The hypothesis is that patients with a severe respiratory form of COVID-19 transported from one health facility to another by the emergency medical service 83 on high-flow nasal oxygen therapy has a reduced risk of intubation compared to the other modes of non-invasive ventilation (NIV) and High Concentration oxygen Masks (HCM).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective observational study in France including COVID-19 infected patients taken care of by the emergency medical service 83 (SAMU 83) for a secondary transport between1st March 2020 and 31th December 2021.

Study Type

Observational

Enrollment (Actual)

229

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Var
      • Toulon, Var, France, 83056
        • Centre Hopitalier Intercommunal Toulon - La Seyne sur Mer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients more than 18 year old taken care of by the emergency medical service 83 (SAMU 83) for secondary transport (transfer from an intensive care unit/other hospital unit/emergency department to another hospital's intensive care unit) between1st March 2020 and 31th December 2021 and without pre-transport intubation

Description

Inclusion Criteria:

  • COVID-positive patient diagnosed either by positive Polymerase Chain Reaction (PCR) or radiological interpretation of chest CT
  • Patient in respiratory distress treated during transport by high flow nasal oxygen or HCM (with a minimum flow of 15 L/min) or other NIV modes
  • Patient taken care of by the emergency medical service 83 (SAMU 83) for secondary transport (transfer from an intensive care unit/other hospital unit/emergency department to another hospital's intensive care unit) between1st March 2020 and 31th December 2021

Exclusion Criteria:

  • Pre-transport intubation
  • Patient opposition to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated by high flow nasal oxygen therapy (Optiflow™)
Device: Use of high flow nasal oxygen therapy
Use of high flow nasal oxygen therapy during secondary transport by emergency medical service 83 (SAMU 83).
Patients treated by other non-invasive ventilation or high concentration oxygen masks
Device: Use of other non-invasive ventilation or high concentration oxygen masks
Use of other non-invasive ventilation or high concentration oxygen masks during secondary transport by emergency medical service 83 (SAMU 83).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation rate
Time Frame: 24 hours
Rate of intubation during the first 24 hours after arrival in the destination Intensive Care Unit (ICU)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 28 days
Rate of patients alive at Day 28.
28 days
ICU length of stay
Time Frame: At the moment of Intensive care unit discharge, up to 1 month
Number of days spent in intensive care unit of destination
At the moment of Intensive care unit discharge, up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Investigators

  • Study Director: BOUTIN Célia, MD, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Actual)

April 25, 2022

Study Completion (Actual)

April 25, 2022

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-CHITS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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