Diving BarotraumaHealthy-divingNCT06555666
Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice (Plongée Santé)
An observational study of Diving Barotrauma, run by University Hospital, Brest at 1 site in France.
Trial summary
The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diving Barotrauma
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 16 Aug 2021to 15 Nov 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The population include new potential divers and confirmed divers who asked for a medical advice about their practice of diving. About a half of this population have had a diving injury or has a chronic pathology.
Who may be able to join
- People who asked for a medical advice for the diving practice in a consultation in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2018/12/31
Who cannot join
- refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice
The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. These people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants.
For the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). A relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner.
Read more
This study aims to analyze the state of health of the service's consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation.
The purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").
Read the detailed description
This is a single-center retrospective study on health data. The methodology includes a collection of data on health and practice of scuba diving, figuring on the medical consultation files and then carrying out a telephone interview of people seen in diving medicine consultation between 01/01/2015 and on 12/31/2018 in the hyperbaric and underwater medicine department of the Brest University hospital.
One month before the start of these interviews, an information letter on the study is sent by post, giving the possibility of opposing it.
The main evaluation criteria are the number of dives carried out since the consultation (and the average number of dives per year of practice), and the number of accidents or incidents during the practice of recreational scuba diving in the framework proposed, during the months or years following the medical consultation The secondary evaluation criteria are the evolution of the chronic pathology, the evolution of health status in general, the number of hours of practice of a physical and sport activity per week, the respect of the technical practice framework recommended.
- Conditions
- Diving Barotrauma
- Keywords
- scuba diving, medical fitness, sport for health
What is being measured
The primary outcome is the main question the study is designed to answer.
injury during diving practice since the consultation
type and number of diving injury
Measured: 1 month
Secondary outcomes (5)
evolution of health status
qualitative scale : new pathology, worse, stable or better
Measured: 1 month
evolution of the chronic pathology
qualitative scale : worse, stable, recurrence or remission
Measured: 1 month
duration of physical or sport practice per week
in hours per week
Measured: 1 month
medical recommendation respect
for each participant, comparison between the medical recommended practice framework and the actual practice declared; then percentage of participant that indicate following the medical recommendation
Measured: 1 month
number of dives carried out since the consultation
average number per year of practice
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 posted15 Aug 2024
- Study start16 Aug 2021
- Primary completion31 Oct 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diving BarotraumaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne HENCKES, Principal investigator, CHRU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555666
- Sponsor's protocol ID
- 29BRC21.0226 - Healthy diving
- Acronym
- Healthy-diving
- Status last verified
- Aug 2023
- First submitted
- 8 Nov 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice of Scuba Diving by as Many People as Possible: Effect of Medical Assessment to Provide a Suitable and Individualised Framework for Practice
- ClinicalTrials.gov ID
- NCT06555666
- Acronym / sponsor ID
- Healthy-diving / 29BRC21.0226 - Healthy diving
- Conditions
- Diving Barotrauma
- Keywords
- scuba diving, medical fitness, sport for health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 15 Aug 2024 (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.
The study focuses on the practice of recreational scuba diving by people who have obtained medical advice for their practice in the hyperbaric and underwater medicine department of the Brest University Hospital. These people may have no health problem or on the contrary consult because they have a pathology and want a medical advice on the impact of this health problem on their practice: this is the case for about the half of these consultants.
For the latter, there are no data concerning the relevance of a medical advice response and a proposal for an appropriate technical practice framework (restriction of dive depth, duration, etc.). A relevant answer results in a practice without diving accidents or decompensation of the pathology and a decision accepted and respected by the practitioner.
This study aims to analyze the state of health of the service's consultants and medical recommendations formulated at the end of this consultation, by retrospective analysis of the consultation files, and to interview the consultants on their practice of diving, their state of health and any problems encountered since their consultation.
The purpose is to validate the hypothesis that a practice of underwater diving is possible and beneficial, with an acceptable risk in case of a risk factor or pathology using a framework of advice and restrictions of adapted and individualized practice ("sport for health").
Detailed description
This is a single-center retrospective study on health data. The methodology includes a collection of data on health and practice of scuba diving, figuring on the medical consultation files and then carrying out a telephone interview of people seen in diving medicine consultation between 01/01/2015 and on 12/31/2018 in the hyperbaric and underwater medicine department of the Brest University hospital.
One month before the start of these interviews, an information letter on the study is sent by post, giving the possibility of opposing it.
The main evaluation criteria are the number of dives carried out since the consultation (and the average number of dives per year of practice), and the number of accidents or incidents during the practice of recreational scuba diving in the framework proposed, during the months or years following the medical consultation The secondary evaluation criteria are the evolution of the chronic pathology, the evolution of health status in general, the number of hours of practice of a physical and sport activity per week, the respect of the technical practice framework recommended.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The population include new potential divers and confirmed divers who asked for a medical advice about their practice of diving. About a half of this population have had a diving injury or has a chronic pathology.
Key inclusion criteria (1 listed)
- People who asked for a medical advice for the diving practice in a consultation in the hyperbaric and underwater medicine department of the Brest University hospital from 2015/01/01 to 2018/12/31
Key exclusion criteria (1 listed)
- refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
injury during diving practice since the consultation
Time frame: 1 month
type and number of diving injury
5 secondary outcomes
evolution of health status
Time frame: 1 month
evolution of the chronic pathology
Time frame: 1 month
duration of physical or sport practice per week
Time frame: 1 month
medical recommendation respect
Time frame: 1 month
number of dives carried out since the consultation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for Diving Barotrauma
Not yet recruitingObservational study
Health, Fitness, and Safety Knowledge as Determinants of Adverse Events in Recreational Divers in Poland
Decompression Sickness, Barotrauma
Recruiting
Impact of Hyperoxia and Involvement of the Immune System in Diving Accident
Decompression Sickness
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.
Anne HENCKES principal investigator
CHRU BREST
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 Diving Barotrauma, run by University Hospital, Brest at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Aug 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
injury during diving practice since the consultation (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 15 Aug 2024.