NCT04250532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 26, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

19 days

First QC Date

January 29, 2020

Last Update Submit

June 4, 2021

Conditions

Drowning

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after inclusion day

Secondary Outcomes (2)

  • Variation of pulse oximetry according to individuals factors

    3 months after inclusion day

  • Variation of pulse oximetry according to environnementals factors

    3 months after inclusion day

Study Arms (1)

Lifeguard

Lifeguards who work on the Atlantic coast of Gironde France.

Other: Drowning

Interventions

DrowningOTHER

Measurement of pulse oximetry, after lifeguard immersion during their morning training

Lifeguard

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lifeguards working on the Girondine Atlantic coast

You may qualify if:

  • Lifeguard working on the Girondine Atlantic coast
  • up to 18 years old,
  • no smoker,
  • No chronic pathology.

You may not qualify if:

  • Chronic cardiac pathology,
  • Chronic respiratory pathology,
  • Acrosyndrome,
  • Smoker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Pellegrin

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Drowning

Condition Hierarchy (Ancestors)

DeathPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

January 31, 2020

Study Start

June 26, 2020

Primary Completion

July 15, 2020

Study Completion

July 15, 2020

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)