NCT03210012

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

25 days

First QC Date

June 28, 2017

Last Update Submit

August 22, 2017

Conditions

Diastolic DysfunctionEndothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Best gas mixture

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

    1 month

Secondary Outcomes (1)

  • diastolic function evaluation

    1 month

Study Arms (1)

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 echocardiographyDiagnostic Test: Blood samples

Interventions

Transthoracic echocardiographyDIAGNOSTIC_TEST

Diagnostic test done prior and after the dive

1
Blood samplesDIAGNOSTIC_TEST

Diagnostic test done prior and after the dive

1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healty volunteer divers

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salvataggio Sub Gambarogno

San Nazzaro, 6575, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for microparticles count

MeSH Terms

Interventions

EchocardiographyBlood Specimen Collection

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, CardiovascularSpecimen HandlingClinical Laboratory TechniquesPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Daniela Cristina, Dr. med.

CONTACT

+41 91 6057788danidott@libero.it

Claudio Camponovo, Dr. med.

CONTACT

+41 91 6116239ccamponovo@arsmedica.ch

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2017

First Posted

July 6, 2017

Study Start

June 11, 2017

Primary Completion

July 6, 2017

Study Completion

August 31, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

CH(1)