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Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions

NCT07492030 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 74

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Necrotizing Fascitis
  • Cellulitis
  • Septic Shock

Interventions

OTHER

Echography

Cardiac output is estimated by taking three measurements of the time-velocity integral using pulsed Doppler at the level of the left ventricular outflow tract, known as the subaortic time-velocity integral (TVI). The systolic ejection volume is calculated by multiplying the subaortic TVI by the area of the aortic outflow tract diameter. Cardiac output is calculated by multiplying this systolic ejection volume by the patient's heart rate. The cardiac index is calculated by dividing cardiac output by the patient's calculated body surface area. Blood gas sampled from central arterial and venous catheters at the four stages of the experimental plan Cardiac output and blood gases will be measured: * After 15 minutes of ventilation on a hyperbaric ventilator at ambient pressure in the chamber with FIO2 equivalent to that of the intensive care unit (T0). * After 15 minutes at maximum treatment pressure, i.e., 2.5 ATA under FIO2 at 1 (T1) * After 75 minutes at the plateau following the star

Sponsors & Collaborators

  • Santelys Association

    collaborator OTHER

  • HyperbaricCare

    collaborator OTHER

  • University Hospital, Lille

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-09-15
Completion
2028-03-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07492030 on ClinicalTrials.gov