DrowningPOSEIDONNCT04250532
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
An observational study of Drowning, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Drowning
- What is being tested?
- Drowning
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2020to 15 Jul 2020
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lifeguards working on the Girondine Atlantic coast
Who may be able to join
- Lifeguard working on the Girondine Atlantic coast
- up to 18 years old,
- no smoker,
- No chronic pathology.
Who cannot join
- Chronic cardiac pathology,
- Chronic respiratory pathology,
- Acrosyndrome,
- Smoker.
Trial locations and contacts
1 site in 1 country.
About this study
Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.
Read the detailed description
The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic coast of Gironde, France, before and after their daily training, using a standardized measurement protocol.
The follow-up will be done during the beach monitoring period during the summer of 2020. A total of 3 months of measurement collection is expected.
- Conditions
- Drowning
- Being tested
- Drowning
- Medical subject headings
- Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrowningOther
Measurement of pulse oximetry, after lifeguard immersion during their morning training
| Study group | Role | What they receive |
|---|---|---|
| Lifeguard | Lifeguards who work on the Atlantic coast of Gironde France. Receives: Other: Drowning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abnormal pulse oximetry measure
Quantify the number of subjects, whose pulse oximetry is measured as abnormal (superior to 94%) after immersion for 15 min in the ocean, in real condition.
Measured: 3 months after inclusion day
Secondary outcomes (2)
Variation of pulse oximetry according to individuals factors
Measures of immersion time, BMI before / after immersion.
Measured: 3 months after inclusion day
Variation of pulse oximetry according to environnementals factors
Measures of air, water temperatures, felt air temperature, wet thermometer temperature, wind speed before / after immersion.
Measured: 3 months after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start26 Jun 2020
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrowningStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250532
- Sponsor's protocol ID
- CHUBX 2019/48
- Acronym
- POSEIDON
- Status last verified
- Jun 2021
- First submitted
- 29 Jan 2020
- Last updated
- 7 Jun 2021
- 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 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
- ClinicalTrials.gov ID
- NCT04250532
- Acronym / sponsor ID
- POSEIDON / CHUBX 2019/48
- Conditions
- Drowning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 31 Jan 2020 (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.
Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in optimal condition and its accuracy can be altered by factors specific to the patient and by environmental factors. The conditions gathered during a drowning rescue are thus propitious to a misleading evaluation. Assessing its reliability and looking for influencing factors of the measure of pulse oximetry could help for pre-hospital care management.
Detailed description
The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic coast of Gironde, France, before and after their daily training, using a standardized measurement protocol.
The follow-up will be done during the beach monitoring period during the summer of 2020. A total of 3 months of measurement collection is expected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifeguard | – | Other: DrowningLifeguards who work on the Atlantic coast of Gironde France. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lifeguards working on the Girondine Atlantic coast
Key inclusion criteria (4 listed)
- Lifeguard working on the Girondine Atlantic coast
- up to 18 years old,
- no smoker,
- No chronic pathology.
Key exclusion criteria (4 listed)
- Chronic cardiac pathology,
- Chronic respiratory pathology,
- Acrosyndrome,
- Smoker.
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 |
|---|---|---|
| DrowningMeasurement of pulse oximetry, after lifeguard immersion during their morning training | Other | Lifeguard |
Primary outcome
Proportion of abnormal pulse oximetry measure
Time frame: 3 months after inclusion day
Quantify the number of subjects, whose pulse oximetry is measured as abnormal (superior to 94%) after immersion for 15 min in the ocean, in real condition.
2 secondary outcomes
Variation of pulse oximetry according to individuals factors
Time frame: 3 months after inclusion day
Variation of pulse oximetry according to environnementals factors
Time frame: 3 months after inclusion day
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 7 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Drowning, run by University Hospital, Bordeaux 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 4 inclusion and 4 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 7 Jun 2021. 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?
Proportion of abnormal pulse oximetry measure (time frame: 3 months after inclusion day). 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 7 Jun 2021.