NCT Number: NCT05049889
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Equipe Résidente de Recherche Subaquatique Opérationnelle, Toulon, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
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:
The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.
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.
Several blood samples will be collected at visit 1 and 2.
Time frame: Until the end of the study (49 months)
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)
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Time frame: Until the end of the study (49 months)
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Contact information is provided by the study sponsor or research team.
Direction Centrale du Service de Santé des Armées
Other
Acronym: RFSI-OPI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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