Diastolic DysfunctionNCT03210012
Bubbles, Stress, Diastole
An observational study of Diastolic Dysfunction and Endothelial Dysfunction, run by Clinica ARS Medica at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diastolic Dysfunction, Endothelial Dysfunction
- What is being tested?
- Transthoracic echocardiography and Blood samples
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Jun 2017to 31 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healty volunteer divers
Who may be able to join
- Age 18 - 60
- healthy subjects
- body mass BMI < a 30
- physical status ASA 1
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Salvataggio Sub Gambarogno
San Nazzaro, 6575
Stefano Beatrizotti, stefano.beatrizotti@gmail.com
Luca Bricalli, lucabricalli@ticino.com
About this study
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).
- Conditions
- Diastolic Dysfunction, Endothelial Dysfunction
- Being tested
- Transthoracic echocardiography, Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDiagnostic test
Diagnostic test done prior and after the dive
Blood samplesDiagnostic test
Diagnostic test done prior and after the dive
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best gas mixture
Best gas mixture with minimal cardiac function impact (endothelial stress)
Measured: 1 month
Secondary outcomes (1)
diastolic function evaluation
diastolic function evaluated after a dive with three different gas mixtures
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start11 Jun 2017
- Primary completion6 Jul 2017
- Study completion31 Aug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastolic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica ARS Medica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Claudio Camponovo, Clinica ARS Medica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210012
- Sponsor's protocol ID
- CMAS1
- Status last verified
- Aug 2017
- First submitted
- 28 Jun 2017
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bubbles, Stress, Diastole
- ClinicalTrials.gov ID
- NCT03210012
- Acronym / sponsor ID
- CMAS1
- Conditions
- Diastolic Dysfunction, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Clinica ARS MedicaUniversity, hospital or other
- Study start
- 11 Jun 2017 (actual)
- Primary completion
- 6 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (estimated)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Transthoracic echocardiography, Diagnostic Test: Blood samplesThree 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) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healty volunteer divers
Key inclusion criteria (4 listed)
- Age 18 - 60
- healthy subjects
- body mass BMI < a 30
- physical status ASA 1
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic echocardiographyDiagnostic test done prior and after the dive | Diagnostic test | 1 |
| Blood samplesDiagnostic test done prior and after the dive | Diagnostic test | 1 |
Primary outcome
Best gas mixture
Time frame: 1 month
Best gas mixture with minimal cardiac function impact (endothelial stress)
1 secondary outcome
diastolic function evaluation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diastolic Dysfunction and Endothelial Dysfunction, run by Clinica ARS Medica at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Cristina, Dr. med. (+41 91 6057788, danidott@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best gas mixture (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.