Clinical trial NCT05775562: Early Pulmonary Effects of Excursion Deep Diving with Closed-circuit Gas Recycling: SPIDD Study
Official title: Early Pulmonary Effects of Excursion Deep Diving with Closed-circuit Gas Recycling: SPIDD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physiopathology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Variation in Vital Capacity Measurement before and after diving
timeFrame: Day 0 (before diving)
measure: Variation in Vital Capacity Measurement before and after diving
timeFrame: Day 0 (after diving)
measure: Variation in Vital Capacity Measurement before and after diving
timeFrame: Day +1
Secondary outcomes:
measure: Variations in Spirometry data before and after diving
timeFrame: Day -XX before diving
measure: Variations in Spirometry data before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in Spirometry data before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in Spirometry data before and after diving
timeFrame: Day +1
measure: Variations in plethysmography data before and after diving
timeFrame: Day -XX before Day 0
measure: Variations in plethysmography data before and after diving
timeFrame: Day -XX before Day 0
measure: Variations in plethysmography data before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in plethysmography data before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in plethysmography data before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in plethysmography data before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in plethysmography data before and after diving
timeFrame: Day +1
measure: Variations in plethysmography data before and after diving
timeFrame: Day +1
measure: Variations in DLCO before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in DLCO before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in DLCO before and after diving
timeFrame: Day +1
measure: Variations in lung ultrasound (B lines) before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in lung ultrasound (B lines) before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in lung ultrasound (B lines) before and after diving
timeFrame: Day +1
measure: Variations in lung ultrasound (condensations) before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in lung ultrasound (condensations) before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in lung ultrasound (condensations) data before and after diving
timeFrame: Day +1
measure: Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in cardiac ultrasound pulmonary pressure (PAPs) before and after diving
timeFrame: Day +1
measure: Variations in right ventricle function data before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in right ventricle function data before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in right ventricle function data before and after diving
timeFrame: Day +1
measure: Variations in decompression (circulating bubbles) data before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in decompression (circulating bubbles) data before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in biological markers of coagulation activation before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in biological markers of coagulation activation before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in biological markers of coagulation activation before and after diving
timeFrame: Day +1
measure: Variations in biomarkers of lipid peroxidation before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in biomarkers of lipid peroxidation before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in biomarkers of lipid peroxidation before and after diving
timeFrame: Day +1
measure: Variations in biomarkers of oxidative stress before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in biomarkers of oxidative stress before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in biomarkers of oxidative stress before and after diving
timeFrame: Day +1
measure: Variations in biological markers of inflammation before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in biological markers of inflammation before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in biological markers of inflammation before and after diving
timeFrame: Day +1
measure: Variations in water balance before and after diving
timeFrame: Day 0 (before diving)
measure: Variations in water balance before and after diving
timeFrame: Day 0 (after diving)
measure: Variations in water balance before and after diving
timeFrame: Day +1
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de BREST
Study officials:
References: