Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Not Applicable

Recruiting

• Conditions: Pulmonary Edema

• 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

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-10
• Study First Posted: 2021-09-20
• Study Start: 2022-08-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14
• Primary Completion: 2026-08
• Study Completion: 2026-08

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

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.

Trial Locations

Locations (2)

Equipe Résidente de Recherche Subaquatique Opérationnelle; 🇫🇷 Toulon, France

Hôpital d'Instruction des Armées Sainte-Anne; 🇫🇷 Toulon, France