NCT05049889

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Direction Centrale du Service de Santé des Armées · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Edema

Interventions

Type	Name	Description
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.
OTHER	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.
DEVICE	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.

Timeline

• Start date: 2022-08-17
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2021-09-20
• Last updated: 2022-09-14

Locations

2 sites across 1 country: France