NCT03210012

Bubbles, Stress, Diastole

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4 (estimated)
• Sponsor: Clinica ARS Medica · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a monocentric pilot study to assess the safety profile of a 30-meter deep underwater diving using 3 different type of gas mixtures: AIR (21% O2 and 79% N2), NITROX 32 (32% O2 And 68% N2) and TRIMIX (21% O2, 44% N2 and 35% He).

Detailed description

The participants will be measured for vital parameters, blood samples and transthoracic cardiac ultrasound before diving (baseline). Participants will be requested to perform recreational dive, which does not require particular decompression stops, at a depth of 30 meters with a 30 minutes botton time. 20 minutes after dive the same measurements as baseline will be repeated, once at rest and once after a physical effort by performing a series of 10 bending on the legs (squats). The day after dive, the participants will be interviewed by phone (FOLLOW-UP) by a physician. It will be required to report any unusual event, MDD symptom, or neurological complication. Same procedure will be repeated with three different type of blends (AIR, NITROX, TRIMIX).

Conditions

• Diastolic Dysfunction
• Endothelial Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transthoracic echocardiography	Diagnostic test done prior and after the dive
DIAGNOSTIC_TEST	Blood samples	Diagnostic test done prior and after the dive

Timeline

• Start date: 2017-06-11
• Primary completion: 2017-07-06
• Completion: 2017-08-31
• First posted: 2017-07-06
• Last updated: 2017-08-23

Locations

1 site across 1 country: Switzerland