Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-17

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The model includes 2 groups:

* 1 group of divers with a history of immersion pulmonary edema
* 1 group of matched divers without a history of immersion pulmonary edema

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

The investigator who will be in charge of the physiological examination will not know the subject's group.

Study Groups

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History of Immersion Pulmonary Edema

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.

Group Type ACTIVE_COMPARATOR

Terrestrial exercise

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

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

No history of Immersion Pulmonary Edema

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.

Group Type ACTIVE_COMPARATOR

Terrestrial exercise

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Transthoracic cardiac ultrasound

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

Intervention Type 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.

Intervention Type DEVICE

Blood collection

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes