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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05049889
Other study ID # 2019PBMD07
Secondary ID 2021-A01225-36
Status Recruiting
Phase N/A
First received
Last updated
Start date August 17, 2022
Est. completion date August 2026

Study information

Verified date September 2022
Source Direction Centrale du Service de Santé des Armées
Contact CASTAGNA Olivier, MD, PhD
Phone 483162830
Email olivier.castagna@intradef.gouv.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident.


Recruitment information / eligibility

Status Recruiting
Enrollment 63
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Military or civilian diver with at least 100 dives - Between the ages of 18 and 60 - Good physical condition (able to run/swim for 30 minutes at a constant pace). Exclusion Criteria: - Divers with a current temporary medical incapacity to dive - Persons with contraindications to physical exercise and/or scuba diving - Pregnant or breastfeeding women

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Terrestrial exercise
At visit 1 (Day 0), an exercise test will be performed (maximal incremental test), followed by a 30-minute submaximal exercise at constant load. During this exercise, continuous data collection will be performed: Continuous 12-lead electrocardiogram Continuous monitoring of blood pressure and ventilation.
Swimming exercise
At visit 2 (Day 7), the subjects will perform a swimming exercise in the experimental pool equipped with a turbine to create a counter-current. The water speed will be constant (4 min per 100 m, i.e. 1.5 km/h). The duration of the exercise will be 30 minutes. Each diver will breathe with the help of a snorkel. During this exercise, continuous data collection will be performed: Continuous 12-lead electrocardiogram Continuous monitoring of blood pressure and ventilation.
Device:
Transthoracic cardiac ultrasound
The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.
Transthoracic pulmonary ultrasound
The participants will have a transthoracic pulmonary ultrasound to quantify the presence of signs of pulmonary vascular overload (comet tails) at visit 1 and 2.
Biological:
Blood collection
Several blood samples will be collected at visit 1 and 2.

Locations

Country Name City State
France Equipe Résidente de Recherche Subaquatique Opérationnelle Toulon
France Hôpital d'Instruction des Armées Sainte-Anne Toulon

Sponsors (1)

Lead Sponsor Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemodynamic modifications of the cardiac cavities after exercise The hemodynamic modifications of the cardiac cavities (before/after exercise) will be measured with transthoracic cardiac ultrasound. Until the end of the study (49 months)
Primary Ventilatory regimes Ventilation regimes will be measured with transthoracic pulmonary ultrasound. Until the end of the study (49 months)
Primary Pulmonary compliance Ventilation regimes will be measured with transthoracic pulmonary ultrasound. Until the end of the study (49 months)
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