Bubbles, Stress, Diastole

• Conditions: Diastolic Dysfunction; Endothelial Dysfunction
• Interventions: Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Blood samples

• Registration Number: NCT03210012
• Lead Sponsor: Clinica ARS Medica

Brief 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).

Study Timeline

• Study Start: 2017-06-11
• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-05
• Primary Completion: 2017-07-06
• Study First Posted: 2017-07-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23
• Study Completion: 2017-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Age 18 - 60
• healthy subjects
• body mass BMI < a 30
• physical status ASA 1

Exclusion Criteria

• subjects with significant clinical impairments such as important head trauma, general pain, low back pain, diabetes, asthma, cardiac and coagulation dysfunctions
• pregnant women
• participation in another study in the last 3 months
• use of drugs and alcohol
• smoking
• psychiatric disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Blood samples	Three dives with different gas mixture : AIR (21% di O2 e 79% di N2), NITROX 32 (32% di O2 e 68% di N2) and TRIMIX (21% O2, 44% N2 e 35% He)
1	Transthoracic echocardiography	Three dives with different gas mixture : AIR (21% di O2 e 79% di N2), NITROX 32 (32% di O2 e 68% di N2) and TRIMIX (21% O2, 44% N2 e 35% He)

Primary Outcome Measures

Name	Time	Method
Best gas mixture	1 month	Best gas mixture with minimal cardiac function impact (endothelial stress)

Secondary Outcome Measures

Name	Time	Method
diastolic function evaluation	1 month	diastolic function evaluated after a dive with three different gas mixtures

Trial Locations

Locations (1)

Salvataggio Sub Gambarogno; 🇨🇭 San Nazzaro, Switzerland