Early Pulmonary Effects of Excursion Deep Diving with Closed-circuit Gas Recycling: SPIDD Study

NCT05775562 | Completed

• 1 other identifier: 29BRC21.0273
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Physiopathology

Outcome Measures

Primary Outcomes (3)

• Variation in Vital Capacity Measurement before and after diving

  Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))

  Day 0 (before diving)

• Variation in Vital Capacity Measurement before and after diving

  Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))

  Day 0 (after diving)

• Variation in Vital Capacity Measurement before and after diving

  Vital capacity measurement will be performed by plethysmography and spirometry (Measurement of mobilizable and non-mobilizable lung volumes (mL))

  Day +1

Secondary Outcomes (44)

• Variations in Spirometry data before and after diving

  Day -XX before diving

• Variations in Spirometry data before and after diving

  Day 0 (before diving)

• Variations in Spirometry data before and after diving

  Day 0 (after diving)

• Variations in Spirometry data before and after diving

  Day +1

• Variations in plethysmography data before and after diving

  Day -XX before Day 0

Study Arms (1)

Diving arm

OTHER

The standard arm involves all participants in the study. Subjects will perform pre-dive and post-dive examinations to characterize the respiratory impact of deep water diving

Diagnostic Test: Pre and post dive examinations

Interventions

Pre and post dive examinations DIAGNOSTIC_TEST

Performing pre-dive examinations: \- EFR by plethysmography cabin Realization of the examinations the day of the dive: * Portable Spirometry * Pulmonary ultrasound * Cardiac ultrasound * Measurement of circulating bubbles * ECG * Venous blood sampling (biological collection) * Water balance (Δweight/water intake) * EFR by plethysmography cabin * Weight measurement Realization of the examinations the day after the dive: * Venous blood sample (biological collection) * Portable Spirometry * Pulmonary ultrasound * Cardiac ultrasound * Weight measurement

Diving arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHU de BREST

Brest, 29200, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: March 20, 2023
• Study Start: September 19, 2023
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (1)