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Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN. (POSEIDON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250532
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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. 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.

Condition or disease Intervention/treatment
Drowning Other: Drowning

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
Estimated Study Start Date : June 30, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drowning

Group/Cohort Intervention/treatment
Lifeguard
Lifeguards who work on the Atlantic coast of Gironde France.
Other: Drowning
Measurement of pulse oximetry, after lifeguard immersion during their morning training




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Variation of pulse oximetry according to individuals factors [ Time Frame: 3 months after inclusion day ]
    Measures of immersion time, BMI before / after immersion.

  2. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Lifeguards working on the Girondine Atlantic coast
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250532


Contacts
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Contact: Eric TELLIER, Dr 5 56 79 56 79 ext +33 eric.tellier@chu-bordeaux.fr
Contact: Samuel MOREAU 5 56 79 56 79 ext +33 samuel.moreau@chu-bordeaux.fr

Locations
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France
Hopital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Eric TELLIER, Dr    0556795679    eric.tellier@chu-bordeaux.fr   
Principal Investigator: Eric TELLIER, Dr         
Sub-Investigator: Bruno SIMONNET, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04250532    
Other Study ID Numbers: CHUBX 2019/48
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drowning
Death
Pathologic Processes
Wounds and Injuries