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Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05049889
Acronym
RFSI-OPI
Enrollment
63
Registered
2021-09-20
Start date
2022-08-17
Completion date
2026-08-31
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Edema

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.

Interventions

OTHERTerrestrial 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.

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.

The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.

DEVICETransthoracic 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.

BIOLOGICALBlood collection

Several blood samples will be collected at visit 1 and 2.

Sponsors

Direction Centrale du Service de Santé des Armées
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Masking description

The investigator who will be in charge of the physiological examination will not know the subject's group.

Intervention model description

The model includes 2 groups: * 1 group of divers with a history of immersion pulmonary edema * 1 group of matched divers without a history of immersion pulmonary edema

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic modifications of the cardiac cavities after exerciseUntil 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 regimesUntil the end of the study (49 months)Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Pulmonary complianceUntil the end of the study (49 months)Ventilation regimes will be measured with transthoracic pulmonary ultrasound.

Countries

France

Contacts

Primary ContactCASTAGNA Olivier, MD, PhD
olivier.castagna@intradef.gouv.fr483162830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026