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

NCT05289141 | Completed

• 1 other identifier: 2022-CHITS-002
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19

Keywords

Coronavirus disease 2019 (COVID-19); Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Nasal High-Flow Oxygen Therapy; Secondary transport by emergency medical service; Non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Intubation rate

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

  24 hours

Secondary Outcomes (2)

• Mortality rate

  28 days

• ICU length of stay

  At the moment of Intensive care unit discharge, up to 1 month

Study Arms (2)

Patients treated by high flow nasal oxygen therapy (Optiflow™)

Device: Use of high flow nasal oxygen therapy

Patients treated by other non-invasive ventilation or high concentration oxygen masks

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

Interventions

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).

Patients treated by high flow nasal oxygen therapy (Optiflow™)

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).

Patients treated by other non-invasive ventilation or high concentration oxygen masks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hopitalier Intercommunal Toulon - La Seyne sur Mer

Toulon, Var, 83056, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• BOUTIN Célia, MD

  Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 21, 2022
• Study Start: March 24, 2022
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)