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Bubbles, Stress, Diastole

C

Clinica ARS Medica

Status

Unknown

Conditions

Diastolic Dysfunction
Endothelial Dysfunction

Treatments

Diagnostic Test: Blood samples
Diagnostic Test: Transthoracic echocardiography

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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).

Enrollment

4 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

4 participants in 1 patient group

1
Description:
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)
Treatment:
Diagnostic Test: Blood samples
Diagnostic Test: Transthoracic echocardiography

Trial contacts and locations

1

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Central trial contact

Claudio Camponovo, Dr. med.; Daniela Cristina, Dr. med.

Data sourced from clinicaltrials.gov

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