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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

3mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4 years study duration

Study Progress94%

Aug 2022Aug 2026

First Submitted

Initial submission to the registry

September 10, 2021

Completed

10 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed

11 months until next milestone

Study Start

First participant enrolled

August 17, 2022

Completed

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

4 years

First QC Date

September 10, 2021

Last Update Submit

September 13, 2022

Conditions

Pulmonary Edema

Outcome Measures

Primary Outcomes (3)

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)
Ventilatory regimes
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Until the end of the study (49 months)
Pulmonary compliance
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Until the end of the study (49 months)

Study Arms (2)

History of Immersion Pulmonary Edema

ACTIVE COMPARATOR

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.

Other: Terrestrial exerciseOther: Swimming exerciseDevice: Transthoracic cardiac ultrasoundDevice: Transthoracic pulmonary ultrasoundBiological: Blood collection

No history of Immersion Pulmonary Edema

ACTIVE COMPARATOR

Other: Terrestrial exerciseOther: Swimming exerciseDevice: Transthoracic cardiac ultrasoundDevice: Transthoracic pulmonary ultrasoundBiological: Blood collection

Interventions

Terrestrial exerciseOTHER

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.