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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2025-A01656-43 |
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| Name | Class |
|---|---|
| Santelys Association | OTHER |
| HyperbaricCare | OTHER |
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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.
Adult patients diagnosed with necrotizing fasciitis and receiving OHB treatment for the first time will be offered participation in the study if they meet the following inclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients diagnosed with necrotizing fasciitis and receiving OHB | Adult patients diagnosed with necrotizing fasciitis and receiving OHB treatment for the first time will be offered participation in the study if they meet the following inclusion criteria:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echography | Other | 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:
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the receiver operating characteristic (ROC) curve constructed from central venous-arterial carbon dioxide tension difference measurements | used to define low cardiac output measured as a cardiac index < 2.2 L/min/m² by cardiac echocardiography under hyperbaric oxygenation conditions after 15 min at the maximum treatment pressure of 2.5 ATA under FIO2 at 1 (T1) Maximum treatment pressure i.e., 2.5 ATA under FIO2 at 1 | After 15 minutes at maximum treatment pressure (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the concordance at different time points (T0, T1, T2, and T3) between the definition of low cardiac output by cardiac index <2.2 L/min/m² (gold standard) and the Pvc-aCO2 value according to the threshold of 6 mmHg. | The concordance between the two variables will be measured using Cohen's Kappa coefficient for each of the four time points. | After 15 minutes at ambiant pressure in the hyperbaric chamber (T0), after 15 minutes at 2.5 ATA under FIO2 at 1 (T1), after 75 minutes following the start of the session (T2), and 15 minutes after the end of HBOT session (T3) |
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Inclusion Criteria:
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
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Adult patients diagnosed with necrotizing dermo-hypodermitis who are receiving OHB treatment for the first time at the Regional Hyperbaric Oxygen Therapy Center at Lille University Hospital, a tertiary referral center where complementary hyperbaric oxygen therapy treatment for necrotizing dermo-hypodermitis in the Hauts-de-France region is centralized.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas DOGNON, Doctor | Contact | 33 3 20 44 55 50 | nicolas.dognon@chu-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'Oxygénothérapie Hyperbare du CHU de Lille | Lille | 59037 | France |
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| ID | Term |
|---|---|
| D019115 | Fasciitis, Necrotizing |
| D002481 | Cellulitis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D012874 | Skin Diseases, Infectious |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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Whole blood samples taken from arterial and central venous catheters during four experimental phases.
|
| Compare cardiac index values measured at T0, T1, T2, and T3 according to three pre-specified groups classified according to Pvc-aCO2 values established by Ospina-Tasco´n et al.: < 6 mmHg; (2) 6.0-9.9 mmHg; (3) ≥ 10 mmHg. | The cardiac index will be measured by cardiac echocardiography under hyperbaric oxygenation conditions. The three groups will be determined according to Pvc-aCO2 values established by Ospina-Tasco´n et al.: (1) < 6 mmHg; (2) 6.0-9.9 mmHg; (3) ≥ 10 mmHg. | After 15 minutes at ambiant pressure in the hyperbaric chamber (T0), after 15 minutes at 2.5 ATA under FIO2 at 1 (T1), after 75 minutes following the start of the session (T2), and 15 minutes after the end of HBOT session (T3) |
| Evaluate the performance of transcutaneous oximetry variations from the subclavian reference electrode after passive leg raising, a non-invasive procedure, as a diagnostic tool for preload dependence. | Area under the receiver operating characteristic (ROC) curve contructed from measurements of transcutaneous oximetry variationsbefore and after passive leg raising (ΔPTcO2). A patient will be considered "preload dependent" if the subaortic ITV measured by echocardiography varies by sup > 10 % under hyperbaric oxygenation conditions after 15 minutes at the maximumtreatment pressure of 2.5 ATA under FIO2 at 1 (T1). The correlation between ΔPTcO2 and the variation in subaortic ITV measured by echocardiography after passive legraising will so also measured. | After 15 minutes at maximum treatment pressure (T1) |
| Describe clinical parameters related to blood pressures, echocardiographic data and respiratory mechanics changes induced in patients admitted for necrotizing fasciitis complicated by septic shock under hyperbaric oxygen therapy. | at each time point (T0, T1, T2, and T3), will be measured :
| After 15 minutes at ambiant pressure in the hyperbaric chamber (T0), after 15 minutes at 2.5 ATA under FIO2 at 1 (T1), after 75 minutes following the start of the session (T2), and 15 minutes after the end of HBOT session (T3) |
| D013492 |
| Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D012769 | Shock |
| D055585 |
| Physical Phenomena |