Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
Not Applicable
Recruiting
- Conditions
- Pulmonary Edema
- Interventions
- Other: Terrestrial exerciseOther: Swimming exerciseDevice: Transthoracic cardiac ultrasoundDevice: Transthoracic pulmonary ultrasoundBiological: Blood collection
- Registration Number
- NCT05049889
- Lead Sponsor
- Direction Centrale du Service de Santé des Armées
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 63
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No history of Immersion Pulmonary Edema Terrestrial exercise 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. History of Immersion Pulmonary Edema Transthoracic pulmonary ultrasound 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. History of Immersion Pulmonary Edema Terrestrial exercise 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. History of Immersion Pulmonary Edema Swimming exercise 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. History of Immersion Pulmonary Edema Transthoracic cardiac ultrasound 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. History of Immersion Pulmonary Edema Blood collection 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. No history of Immersion Pulmonary Edema Swimming exercise 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. No history of Immersion Pulmonary Edema Transthoracic cardiac ultrasound 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. No history of Immersion Pulmonary Edema Transthoracic pulmonary ultrasound 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. No history of Immersion Pulmonary Edema Blood collection 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.
- Primary Outcome Measures
Name Time Method Hemodynamic modifications of the cardiac cavities after exercise 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.
Ventilatory regimes Until the end of the study (49 months) Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Pulmonary compliance Until the end of the study (49 months) Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hôpital d'Instruction des Armées Sainte-Anne
🇫🇷Toulon, France
Equipe Résidente de Recherche Subaquatique Opérationnelle
🇫🇷Toulon, France