Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDirection Centrale du Service de Santé des Armées

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Terrestrial exercise

    Other intervention

    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

    Other intervention

    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.

  • Transthoracic cardiac ultrasound

    Device

    The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.

  • Transthoracic pulmonary ultrasound

    Device

    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.

  • Blood collection

    Biological/Vaccine

    Several blood samples will be collected at visit 1 and 2.

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: History of Immersion Pulmonary EdemaActive comparator 5 interventions
Group B: No history of Immersion Pulmonary EdemaActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Until the end of the study (49 months)
2

Ventilatory regimes

Ventilation regimes will be measured with transthoracic pulmonary ultrasound.

Time frame
Until the end of the study (49 months)
3

Pulmonary compliance

Ventilation regimes will be measured with transthoracic pulmonary ultrasound.

Time frame
Until the end of the study (49 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

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