- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250532
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN. (POSEIDON)
June 4, 2021 updated by: University Hospital, Bordeaux
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
31
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bordeaux, France, 33000
- Hôpital Pellegrin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Lifeguards working on the Girondine Atlantic coast
Description
Inclusion Criteria:
- Lifeguard working on the Girondine Atlantic coast
- up to 18 years old,
- no smoker,
- No chronic pathology.
Exclusion Criteria:
- Chronic cardiac pathology,
- Chronic respiratory pathology,
- Acrosyndrome,
- Smoker.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Lifeguard
Lifeguards who work on the Atlantic coast of Gironde France.
|
Measurement of pulse oximetry, after lifeguard immersion during their morning training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months after inclusion day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of pulse oximetry according to individuals factors
Time Frame: 3 months after inclusion day
|
Measures of immersion time, BMI before / after immersion.
|
3 months after inclusion day
|
Variation of pulse oximetry according to environnementals factors
Time Frame: 3 months after inclusion day
|
Measures of air, water temperatures, felt air temperature, wet thermometer temperature, wind speed before / after immersion.
|
3 months after inclusion day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2020
Primary Completion (Actual)
July 15, 2020
Study Completion (Actual)
July 15, 2020
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
June 7, 2021
Last Update Submitted That Met QC Criteria
June 4, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2019/48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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