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Bubbles, Stress, Diastole

Bubbles, Stress, Diastole

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03210012
Enrollment
4
Registered
2017-07-06
Start date
2017-06-11
Completion date
2017-08-31
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Endothelial Dysfunction

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).

Interventions

DIAGNOSTIC_TESTTransthoracic echocardiography

Diagnostic test done prior and after the dive

DIAGNOSTIC_TESTBlood samples

Diagnostic test done prior and after the dive

Sponsors

Clinica ARS Medica
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Best gas mixture1 monthBest gas mixture with minimal cardiac function impact (endothelial stress)

Secondary

MeasureTime frameDescription
diastolic function evaluation1 monthdiastolic function evaluated after a dive with three different gas mixtures

Countries

Switzerland

Contacts

Primary ContactDaniela Cristina, Dr. med.
danidott@libero.it+41 91 6057788
Backup ContactClaudio Camponovo, Dr. med.
ccamponovo@arsmedica.ch+41 91 6116239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026