Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Terrestrial exercise, Swimming exercise, Transthoracic cardiac ultrasound, Transthoracic pulmonary ultrasound.
- Who it may be relevant to
- Registry conditions: Pulmonary Edema. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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. - 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. - Device Transthoracic cardiac ultrasound
The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2. - 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. - Biological Blood collection
Several blood samples will be collected at visit 1 and 2.
Primary outcome measures
- Hemodynamic modifications of the cardiac cavities after exercise [Time frame: Until the end of the study (49 months)]
- Ventilatory regimes [Time frame: Until the end of the study (49 months)]
- Pulmonary compliance [Time frame: Until the end of the study (49 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
France · 2 centers
- Equipe Résidente de Recherche Subaquatique Opérationnelle — Toulon
- Hôpital d'Instruction des Armées Sainte-Anne — Toulon
Identifiers
NCT: NCT05049889 · 2019PBMD07 · 2021-A01225-36