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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01225-36 | Other Identifier | IDRCB |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| History of Immersion Pulmonary Edema | Active Comparator | 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. |
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| No history of Immersion Pulmonary Edema | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terrestrial exercise | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Ventilatory regimes | Ventilation regimes will be measured with transthoracic pulmonary ultrasound. | Until the end of the study (49 months) |
| Pulmonary compliance | Ventilation regimes will be measured with transthoracic pulmonary ultrasound. | Until the end of the study (49 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CASTAGNA Olivier, MD, PhD | Contact | 483162830 | +33 | olivier.castagna@intradef.gouv.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Equipe Résidente de Recherche Subaquatique Opérationnelle | Recruiting | Toulon | 83800 | France |
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| ID | Term |
|---|---|
| D011654 | Pulmonary Edema |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The model includes 2 groups:
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The investigator who will be in charge of the physiological examination will not know the subject's group.
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| Swimming exercise | 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:
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| 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. |
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| 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. |
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| Blood collection | Biological | Several blood samples will be collected at visit 1 and 2. |
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| Hôpital d'Instruction des Armées Sainte-Anne | Recruiting | Toulon | 83800 | France |
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| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |