COVID-19SAMU83NCT05289141
Interest in the Use of Nasal High-Flow Oxygen Therapy (OptiFlow™) in Secondary Transport of COVID-19 Positive Patients
An observational study of COVID-19, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Use of high flow nasal oxygen therapy and Use of other non-invasive ventilation or high concentration oxygen masks
- Type of treatment
- Medical device
- How many people
- 229 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2022to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Pre-transport intubation
- Patient opposition to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hopitalier Intercommunal Toulon - La Seyne sur Mer
Toulon, Var, 83056
About this study
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).
Read more
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).
Read the 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.
- Conditions
- COVID-19
- Being tested
- Use of high flow nasal oxygen therapy, Use of other non-invasive ventilation or high concentration oxygen masks
- 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
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of high flow nasal oxygen therapyDevice
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 masksDevice
Use of other non-invasive ventilation or high concentration oxygen masks during secondary transport by emergency medical service 83 (SAMU 83).
| Study group | Role | What they receive |
|---|---|---|
| Patients treated by high flow nasal oxygen therapy (Optiflow™) | Not described Receives: Device: Use of high flow nasal oxygen therapy | |
| Patients treated by other non-invasive ventilation or high concentration oxygen masks | Not described Receives: Device: Use of other non-invasive ventilation or high concentration oxygen masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation rate
Rate of intubation during the first 24 hours after arrival in the destination Intensive Care Unit (ICU)
Measured: 24 hours
Secondary outcomes (2)
Mortality rate
Rate of patients alive at Day 28.
Measured: 28 days
ICU length of stay
Number of days spent in intensive care unit of destination
Measured: At the moment of Intensive care unit discharge, up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start24 Mar 2022
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOUTIN Célia, MD, Study director, Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289141
- Sponsor's protocol ID
- 2022-CHITS-002
- Acronym
- SAMU83
- Status last verified
- Oct 2022
- First submitted
- 18 Mar 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest in the Use of Nasal High-Flow Oxygen Therapy (OptiFlow™) in Secondary Transport of COVID-19 Positive Patients
- ClinicalTrials.gov ID
- NCT05289141
- Acronym / sponsor ID
- SAMU83 / 2022-CHITS-002
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Pre-transport intubation
- Patient opposition to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of high flow nasal oxygen therapyUse of high flow nasal oxygen therapy during secondary transport by emergency medical service 83 (SAMU 83). | Device | Patients treated by high flow nasal oxygen therapy (Optiflow™) |
| Use of other non-invasive ventilation or high concentration oxygen masksUse of other non-invasive ventilation or high concentration oxygen masks during secondary transport by emergency medical service 83 (SAMU 83). | Device | Patients treated by other non-invasive ventilation or high concentration oxygen masks |
Primary outcome
Intubation rate
Time frame: 24 hours
Rate of intubation during the first 24 hours after arrival in the destination Intensive Care Unit (ICU)
2 secondary outcomes
Mortality rate
Time frame: 28 days
ICU length of stay
Time frame: At the moment of Intensive care unit discharge, up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOUTIN Célia, MD study director
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubation rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.