search
Back to results

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema (RFSI-OPI)

Primary Purpose

Pulmonary Edema

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Terrestrial exercise
Swimming exercise
Transthoracic cardiac ultrasound
Transthoracic pulmonary ultrasound
Blood collection
Sponsored by
Direction Centrale du Service de Santé des Armées
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pulmonary Edema

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Equipe Résidente de Recherche Subaquatique OpérationnelleRecruiting
  • Hôpital d'Instruction des Armées Sainte-AnneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

History of Immersion Pulmonary Edema

No history of Immersion Pulmonary Edema

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Ventilatory regimes
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Pulmonary compliance
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2021
Last Updated
September 13, 2022
Sponsor
Direction Centrale du Service de Santé des Armées
search

1. Study Identification

Unique Protocol Identification Number
NCT05049889
Brief Title
Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
Acronym
RFSI-OPI
Official Title
Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Direction Centrale du Service de Santé des Armées

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Edema

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Outcomes Assessor
Masking Description
The investigator who will be in charge of the physiological examination will not know the subject's group.
Allocation
Non-Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
History of Immersion Pulmonary Edema
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No history of Immersion Pulmonary Edema
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Terrestrial exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Swimming exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transthoracic cardiac ultrasound
Intervention Description
The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.
Intervention Type
Device
Intervention Name(s)
Transthoracic pulmonary ultrasound
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Blood collection
Intervention Description
Several blood samples will be collected at visit 1 and 2.
Primary Outcome Measure Information:
Title
Hemodynamic modifications of the cardiac cavities after exercise
Description
The hemodynamic modifications of the cardiac cavities (before/after exercise) will be measured with transthoracic cardiac ultrasound.
Time Frame
Until the end of the study (49 months)
Title
Ventilatory regimes
Description
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Time Frame
Until the end of the study (49 months)
Title
Pulmonary compliance
Description
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Time Frame
Until the end of the study (49 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CASTAGNA Olivier, MD, PhD
Phone
483162830
Ext
+33
Email
olivier.castagna@intradef.gouv.fr
Facility Information:
Facility Name
Equipe Résidente de Recherche Subaquatique Opérationnelle
City
Toulon
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier CASTAGNA, MD, PhD
Phone
483162830
Ext
+33
Email
olivier.castagna@intradef.gouv.fr
Facility Name
Hôpital d'Instruction des Armées Sainte-Anne
City
Toulon
ZIP/Postal Code
83800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Eric BLATTEAU, MD, PhD
Phone
483162189
Ext
+33
Email
jean-eric.blatteau@intradef.gouv.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema

We'll reach out to this number within 24 hrs