Evaluation of Full Face Snorkel Masks (FFSMs)

NCT04783688 | Completed

• 1 other identifier: Pro00106241
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Recently, multiple models of Full Face Snorkel Mask (FFSM) have entered the retail market. However, several fatalities have been reported to the non-profit agency Divers Alert Network (DAN) for snorkelers who were using FFSMs, and most of these fatality reports have unclear or unreported causes of death. This project is to determine the characteristics of the FFSMs when they are in use by snorkelers. Volunteers will be asked to snorkel in a water tank while breathing through several models of commercially available FFSM, one at at time.

Conditions

Snorkeling; Face Mask Squeeze; Underwater Physiology; Swimming Physiology

Outcome Measures

Primary Outcomes (2)

• Fractional level of oxygen in the breathing gas (at steady state) provided by the different mask models

  The breathing gas provided to the snorkeler by the masks will be measured continuously throughout the experiment using a mass spectrometer.

  Estimated 4 hours long

• Fractional level of carbon dioxide in the breathing gas (at steady state) provided by the different mask models

  The breathing gas provided to the snorkeler by the masks will be measured continuously throughout the experiment using a mass spectrometer.

  Estimated 4 hours long

Secondary Outcomes (1)

• Speed of removal of the different FFSM models

  Estimated 20 minutes

Study Arms (1)

Experimental Group

EXPERIMENTAL

All subjects will snorkel using the same FFSMs.

Other: Full Face Snorkel Mask (FFSM)

Interventions

Full Face Snorkel Mask (FFSM) OTHER

A mask used for snorkeling that covers the entire face, as opposed to a conventional snorkel, which is held in the mouth only.

Experimental Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Preferred \>35 years old
• Safe to perform light activity

You may not qualify if:

• Subjects must NOT be certified SCUBA divers
• GROUP B:
• Age 18-40
• VO2max exercise test results \>30 mL/kg/min for female, \>35 mL/kg/min for male
• Subjects must NOT be certified SCUBA divers
• May not be active smokers

Sponsors & Collaborators

• Duke University: lead
• Divers Alert Network: collaborator

Study Sites (1)

Duke University Center for Hyperbaric Medicine & Environmental Physiology

Durham, North Carolina, 27710, United States

Location

Study Officials

• Rachel Lance, PhD

  Duke University Health System, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study is a measurement of subjects performing normal tasks in a controlled environment, with physiological measurements

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 9, 2021
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: July 14, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)