Bubbles, Stress, Diastole

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).

Study Overview

• Status: Unknown
• Conditions: Endothelial Dysfunction; Diastolic Dysfunction
• Intervention / Treatment: Diagnostic test: Transthoracic echocardiography; Diagnostic test: Blood samples

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 Type: Observational
• Enrollment (Anticipated): 4

Contacts and Locations

Study Locations

• Switzerland
  • San Nazzaro, Switzerland, 6575
    • Recruiting
    • Salvataggio Sub Gambarogno
    • Contact: Stefano Beatrizotti; Email: stefano.beatrizotti@gmail.com
    • Contact: Luca Bricalli; Email: lucabricalli@ticino.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healty volunteer divers

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; 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)	Diagnostic test: Transthoracic echocardiography; Diagnostic test done prior and after the dive; Diagnostic test: Blood samples; Diagnostic test done prior and after the dive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best gas mixture	Best gas mixture with minimal cardiac function impact (endothelial stress)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic function evaluation	diastolic function evaluated after a dive with three different gas mixtures	1 month

Collaborators and Investigators

• Sponsor: Clinica ARS Medica

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2017
• Primary Completion (Actual): July 6, 2017
• Study Completion (Anticipated): August 31, 2017

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CMAS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No