Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN. | NCT04250532

Studies
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.

NCT04250532

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Jun 7, 2021Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Drowning

Interventions

Drowning

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2020Actual

Primary Completion Date

Jul 15, 2020Actual

Completion Date

Jul 15, 2020Actual

First Submitted Date

Jan 29, 2020

First Submission Date that Met QC Criteria

Jan 29, 2020

First Posted Date

Jan 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2021

Last Update Posted Date

Jun 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifeguard		Lifeguards who work on the Atlantic coast of Gironde France.	Other: Drowning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drowning	Other	Measurement of pulse oximetry, after lifeguard immersion during their morning training	Lifeguard

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Variation of pulse oximetry according to individuals factors	Measures of immersion time, BMI before / after immersion.	3 months after inclusion day
Variation of pulse oximetry according to environnementals factors

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Lifeguards working on the Girondine Atlantic coast

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Pellegrin		Bordeaux		33000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004332	Drowning

Ancestor Terms

ID	Term
D003643	Death
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided