Early Pulmonary Effects of Excursion Deep Diving With Closed-circuit Gas Recycling: SPIDD Study (NCT05775562) | Clinical Trial Compass
CompletedNot Applicable
Early Pulmonary Effects of Excursion Deep Diving With Closed-circuit Gas Recycling: SPIDD Study
France20 participantsStarted 2023-09-19
Plain-language summary
Scuba diving with closed circuit gas rebreathers is currently booming. Initially developed for professional and military diving, this type of diving has become very successful in recreational activities.
The possibilities offered by this equipment are immense and reduce the constraints of exploration time and depth. More and more divers are seeking to reach depths previously considered unusual or inaccessible in recreational diving, beyond 100 meters. By pushing back these limits, the diver is exposed to new risks which should lead to a reflection on the means of prevention and treatment in case of incident.
The physiological repercussions of these deep dives are not well known. During daily deep excursions in the 90-120 meter zone, there is a significant reduction in vital capacity on leaving the dive, which persists and worsens the following day.
It seems necessary to confirm the importance of this impairment, never documented before, and to explore its mechanisms. A better knowledge of this respiratory impact could allow to improve the prevention and the preliminary evaluation of the medical aptitude of these divers.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diver ≥ 18 years old
* Recreational rebreather diver with a recognised qualification (Mixed Gas CCR training or equivalent) and the necessary experience for this type of diving who has scheduled a dive in the 60 metre depth zone
* Diver using his/her own equipment, i.e. a closed circuit rebreather with back lungs meeting CE standards.
* Having a medical certificate of no contraindication to the practice of underwater activities \< 1 year issued by an authorised doctor
* Having taken out personal insurance covering this type of activity
* Voluntary and having given his/her express, free and informed consent
* Affiliated to the Social Security
Exclusion Criteria:
* Diver refusal
* Known previous respiratory pathology
* Use of medication that may alter pulmonary and/or vascular function as well as inflammatory and haemostasis parameters
* Any temporary contraindication to the practice of scuba diving
* Patient under guardianship or trusteeship
* Immersion beyond 30 metres within 7 days or any scuba diving within the previous 48 hours.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Variation in Vital Capacity Measurement before and after diving
Timeframe: Day 0 (before diving)
2
Variation in Vital Capacity Measurement before and after diving
Timeframe: Day 0 (after diving)
3
Variation in Vital Capacity Measurement before and after diving