Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Pulmonary Edema Clinical Trial

— RFSI-OPI  

Official title:

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049889
• Other study ID #: 2019PBMD07
• Secondary ID: 2021-A01225-36
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: August 2026

Study information

• Verified date: September 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: CASTAGNA Olivier, MD, PhD
• Phone: 483162830
• Email: olivier.castagna[@]intradef.gouv.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Edema
• Pulmonary Edema

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
France	Equipe Résidente de Recherche Subaquatique Opérationnelle	Toulon
France	Hôpital d'Instruction des Armées Sainte-Anne	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Ventilatory regimes	Ventilation regimes will be measured with transthoracic pulmonary ultrasound.	Until the end of the study (49 months)
Primary	Pulmonary compliance	Ventilation regimes will be measured with transthoracic pulmonary ultrasound.	Until the end of the study (49 months)