Bubbles, Stress, Diastole

Endothelial Dysfunction Clinical Trial

Official title:

Bubbles, Stress, Diastole

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03210012
• Other study ID #: CMAS1
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2017
• Last updated: August 22, 2017
• Start date: June 11, 2017
• Est. completion date: August 31, 2017

Study information

• Verified date: August 2017
• Source: Clinica ARS Medica
• Contact: Daniela Cristina, Dr. med.
• Phone: +41 91 6057788
• Email: danidott[@]libero.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: August 31, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Endothelial Dysfunction

Intervention

Diagnostic Test:
• Transthoracic echocardiography
Diagnostic test done prior and after the dive
• Blood samples
Diagnostic test done prior and after the dive

Locations

Country	Name	City	State
Switzerland	Salvataggio Sub Gambarogno	San Nazzaro

Sponsors (1)

Lead Sponsor	Collaborator
Clinica ARS Medica

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best gas mixture	Best gas mixture with minimal cardiac function impact (endothelial stress)	1 month
Secondary	diastolic function evaluation	diastolic function evaluated after a dive with three different gas mixtures	1 month