Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema (RFSI-OPI)

Direction Centrale du Service de Santé des Armées

Status: Enrolling

Conditions: Pulmonary Edema

Treatments: Other: Swimming exercise; Device: Transthoracic cardiac ultrasound; Biological: Blood collection; Device: Transthoracic pulmonary ultrasound; Other: Terrestrial exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05049889

2019PBMD07

2021-A01225-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 63 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

History of Immersion Pulmonary Edema

Active Comparator group

Description:

The participants will have 2 visits: At visit 1 (Day 0), the participants will perform a terrestrial exercise, have a transthoracic cardiac ultrasound, a transthoracic pulmonary ultrasound and several blood samples will be collected. At visit 2 (Day 7), the participants will perform a swimming exercise, have a transthoracic cardiac ultrasound, a transthoracic pulmonary ultrasound and several blood samples will be collected.

Treatment:

Biological: Blood collection

Other: Swimming exercise

Device: Transthoracic cardiac ultrasound

Device: Transthoracic pulmonary ultrasound

Other: Terrestrial exercise

No history of Immersion Pulmonary Edema

Active Comparator group

Description:

The participants will have 2 visits: At visit 1 (Day 0), the participants will perform a terrestrial exercise, have a transthoracic cardiac ultrasound, a transthoracic pulmonary ultrasound and several blood samples will be collected. At visit 2 (Day 7), the participants will perform a swimming exercise, have a transthoracic cardiac ultrasound, a transthoracic pulmonary ultrasound and several blood samples will be collected.

Treatment:

Biological: Blood collection

Other: Swimming exercise

Device: Transthoracic cardiac ultrasound

Device: Transthoracic pulmonary ultrasound

Other: Terrestrial exercise