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Completed

NCT Number: NCT05289141

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

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).

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hopitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, Var, 83056, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of high flow nasal oxygen therapy

Device

Use of high flow nasal oxygen therapy during secondary transport by emergency medical service 83 (SAMU 83).

Use of other non-invasive ventilation or high concentration oxygen masks

Device

Use of other non-invasive ventilation or high concentration oxygen masks during secondary transport by emergency medical service 83 (SAMU 83).

Primary outcomes

  1. Intubation rate

    Time frame: 24 hours

    Rate of intubation during the first 24 hours after arrival in the destination Intensive Care Unit (ICU)

Secondary outcomes

  1. Mortality rate

    Time frame: 28 days

    Rate of patients alive at Day 28.

  2. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Registry information

Acronym: SAMU83

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2022
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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