Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions (NCT07492030) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions
France74 participantsStarted 2026-06-15
Plain-language summary
The central venous-arterial carbon dioxide tension difference is used daily in intensive care to establish peripheral tissue hypoperfusion, mainly mediated by a low cardiac index.
The partial pressures of gases (oxygen, carbon dioxide) increase in the blood of patients breathing 100% oxygen in hyperbaric conditions.
Thus, the validity of this biomarker in situations of acute circulatory failure during a hyperbaric oxygen therapy session has not been established.
The objective of the study is therefore to establish the diagnostic performance of the central venous-arterial carbon dioxide tension difference in the diagnosis of a low cardiac index in patients with septic shock undergoing hyperbaric oxygen therapy for necrotizing fasciitis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of necrotizing fasciitis complicated by septic shock as defined by the Surviving Sepsis Campaign
* Indication for HBOT according to the criteria of the 2016 European Consensus Conference
* Patient intubated and ventilated prior to the HBOT session, receiving intravenous sedation at doses sufficient to be in a passive ventilation state
* Patient equipped with a central venous line in the superior vena cava allowing central venous blood gas analysis
* Patient with an arterial catheter allowing arterial blood gas analysis
Exclusion Criteria:
* \- Minors
* Pregnant women
* Persons deprived of their liberty (prisoners, persons under guardianship or trusteeship)
* Persons not affiliated with or not covered by a social security system
* Patients on spontaneous ventilation
* Patients without an echocardiographic assessment window (anechoic)
* Severe ARDS according to the Berlin classification
* Technical impossibility of sampling central arterial or venous blood
* Absolute contraindication to hyperbaric oxygen therapy (undrained pneumothorax, unstable angina or acute myocardial infarction, severe asthma attack)
* Relative contraindication to hyperbaric oxygen therapy
* Respiratory: Chronic respiratory failure, severe pulmonary emphysema
* Circulatory: Rhythm or conduction disorders
* Neurological: uncontrolled epilepsy
* ENT: sinusitis, otitis, chronic rhinitis; laryngocele; acute otitis media; osteospongiosis
* Ophthalmic: retinal detach…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area under the receiver operating characteristic (ROC) curve constructed from central venous-arterial carbon dioxide tension difference measurements
Timeframe: After 15 minutes at maximum treatment pressure (T1)