Pulmonary EdemaRFSI-OPINCT05049889
Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
A study testing Terrestrial exercise, Swimming exercise and Transthoracic cardiac ultrasound in people with Pulmonary Edema, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Edema
- What is being tested?
- Terrestrial exercise, Swimming exercise and Transthoracic cardiac ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Aug 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- Divers with a current temporary medical incapacity to dive
- Persons with contraindications to physical exercise and/or scuba diving
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Equipe Résidente de Recherche Subaquatique Opérationnelle
Toulon, 83800
Olivier CASTAGNA, MD, PhD, 483162830 ext. +33, olivier.castagna@intradef.gouv.fr
- Recruiting
Hôpital d'Instruction des Armées Sainte-Anne
Toulon, 83800
Jean-Eric BLATTEAU, MD, PhD, 483162189 ext. +33, jean-eric.blatteau@intradef.gouv.fr
About this study
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.
- Conditions
- Pulmonary Edema
- Being tested
- Terrestrial exercise, Swimming exercise, Transthoracic cardiac ultrasound, Transthoracic pulmonary ultrasound, Blood collection
- Medical subject headings
- Pulmonary Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Swimming exerciseOther
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.
Transthoracic cardiac ultrasoundDevice
The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.
Transthoracic pulmonary ultrasoundDevice
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.
Blood collectionBiological
Several blood samples will be collected at visit 1 and 2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Terrestrial exercise; Other: Swimming exercise; Device: Transthoracic cardiac ultrasound; Device: Transthoracic pulmonary ultrasound; Biological: Blood collection |
| No 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. Receives: Other: Terrestrial exercise; Other: Swimming exercise; Device: Transthoracic cardiac ultrasound; Device: Transthoracic pulmonary ultrasound; Biological: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until the end of the study (49 months)
Ventilatory regimes
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Measured: Until the end of the study (49 months)
Pulmonary compliance
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Measured: Until the end of the study (49 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start17 Aug 2022
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direction Centrale du Service de Santé des Armées
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049889
- Sponsor's protocol ID
- 2019PBMD07
- Other IDs
- 2021-A01225-36
- Acronym
- RFSI-OPI
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema
- ClinicalTrials.gov ID
- NCT05049889
- Acronym / sponsor ID
- RFSI-OPI / 2019PBMD07
- Conditions
- Pulmonary Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Direction Centrale du Service de Santé des ArméesUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| History of Immersion Pulmonary Edema | Active comparator | Other: Terrestrial exercise, Other: Swimming exercise, Device: Transthoracic cardiac ultrasound, Device: Transthoracic pulmonary ultrasound, Biological: Blood collectionThe 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. |
| No history of Immersion Pulmonary Edema | Active comparator | Other: Terrestrial exercise, Other: Swimming exercise, Device: Transthoracic cardiac ultrasound, Device: Transthoracic pulmonary ultrasound, Biological: Blood collectionThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- Divers with a current temporary medical incapacity to dive
- Persons with contraindications to physical exercise and/or scuba diving
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terrestrial exerciseAt 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. | Other | History of Immersion Pulmonary Edema, No history of Immersion Pulmonary Edema |
| Swimming exerciseAt 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. | Other | History of Immersion Pulmonary Edema, No history of Immersion Pulmonary Edema |
| Transthoracic cardiac ultrasoundThe participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2. | Device | History of Immersion Pulmonary Edema, No history of Immersion Pulmonary Edema |
| Transthoracic pulmonary ultrasoundThe participants will have a transthoracic pulmonary ultrasound to quantify the presence of signs of pulmonary vascular overload (comet tails) at visit 1 and 2. | Device | History of Immersion Pulmonary Edema, No history of Immersion Pulmonary Edema |
| Blood collectionSeveral blood samples will be collected at visit 1 and 2. | Biological | History of Immersion Pulmonary Edema, No history of Immersion Pulmonary Edema |
Primary outcome
Hemodynamic modifications of the cardiac cavities after exercise
Time frame: 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
Time frame: Until the end of the study (49 months)
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Pulmonary compliance
Time frame: Until the end of the study (49 months)
Ventilation regimes will be measured with transthoracic pulmonary ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terrestrial exercise, Swimming exercise and Transthoracic cardiac ultrasound in people with Pulmonary Edema, run by Direction Centrale du Service de Santé des Armées at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CASTAGNA Olivier, MD, PhD (483162830 ext. +33, olivier.castagna@intradef.gouv.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic modifications of the cardiac cavities after exercise (time frame: Until the end of the study (49 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.