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

COVID-19 Clinical Trial

— SAMU83  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05289141
• Other study ID #: 2022-CHITS-002
• Status: Completed
• Start date: March 24, 2022
• Est. completion date: April 25, 2022

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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).
• 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).

Locations

Country	Name	City	State
France	Centre Hopitalier Intercommunal Toulon - La Seyne sur Mer	Toulon	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation rate	Rate of intubation during the first 24 hours after arrival in the destination Intensive Care Unit (ICU)	24 hours
Secondary	Mortality rate	Rate of patients alive at Day 28.	28 days
Secondary	ICU length of stay	Number of days spent in intensive care unit of destination	At the moment of Intensive care unit discharge, up to 1 month