CClinicalTrials.gg
Status unknownNCT03210012Updated Aug 23, 2017

Bubbles, Stress, Diastole

An observational study in Diastolic Dysfunction and Endothelial Dysfunction, sponsored by Clinica ARS Medica. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-23.

Sponsored by Clinica ARS Medica · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
4
Ages
18 Years to 60 Years
Sex
All
01

Study 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).

Read the 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).

02

Conditions studied

  • Diastolic Dysfunction
  • Endothelial Dysfunction
03

In context

Lead sponsor

Clinica ARS Medica is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healty volunteer divers

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
4 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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: Blood samples

Interventions

  • Diagnostic testTransthoracic echocardiography

    Diagnostic test done prior and after the dive

  • Diagnostic testBlood samples

    Diagnostic test done prior and after the dive

06

What researchers measure

Primary outcomes

  1. Best gas mixture

    Best gas mixture with minimal cardiac function impact (endothelial stress)

    Time frame: 1 month

Secondary outcomes

  1. diastolic function evaluation

    diastolic function evaluated after a dive with three different gas mixtures

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03210012
Lead sponsor
Clinica ARS Medica
Responsible party
Dr. med. Claudio Camponovo (Principal Investigator, Clinica ARS Medica) — Principal investigator
First posted
Jul 6, 2017
Start date
Jun 11, 2017
Primary completion
Jul 6, 2017
Completion
Aug 31, 2017 (estimated)
Last update
Aug 23, 2017

Study contacts

Daniela Cristina, Dr. med.
Contact
danidott@libero.it
+41 91 6057788
Claudio Camponovo, Dr. med.
Contact
ccamponovo@arsmedica.ch
+41 91 6116239

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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