Necrotizing FascitisSEPTICO2HBONCT07492030
Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions
An observational study of Necrotizing Fascitis and Cellulitis, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Fascitis, Cellulitis, Septic Shock
- What is being tested?
- Echography
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2026to 15 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- - 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)
Show all 15Show fewer
- 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 detachment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Centre d'Oxygénothérapie Hyperbare du CHU de Lille
Lille, 59037
Nicolas DOGNON, Doctor, 33 3 20 44 55 50, nicolas.dognon@chu-lille.fr
About this study
Official title: Use of Central Venous-arterial Carbon Dioxide Tension Difference to Diagnose Low Cardiac Output in Patients With Septic Shock Undergoing Hyperbaric Oxygen Therapy
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.
Read more
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.
Read the detailed description
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:
- 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
- Conditions
- Necrotizing Fascitis, Cellulitis, Septic Shock
- Being tested
- Echography
- Keywords
- HBO, gapCO2, necrotizing fascitis, cellulitis, cardiac index
- Medical subject headings
- Fasciitis, Necrotizing, Cellulitis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchographyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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 Receives: Other: Echography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 15 minutes at maximum treatment pressure (T1)
Secondary outcomes (4)
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.
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)
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.
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)
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.
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 :
- Systolic/diastolic/mean arterial pressures
- Heart rate
- Systolic/diastolic/mean pulmonary arterial pressures estimated by transthoracic echocardiography
- End-expiratory central venous pressure by transthoracic echocardiography through analysis of the inferior vena cava.
- Cardiac index estimated by echocardiography
- TAPSE and S' wave,
- Mitral flow analysis
- Indexed systemic vascular resistance estimated using Ohm's law. (PAM-PVC)/IC
- Indexed pulmonary vascular resistance estimated using the formula : RPT = 10 (Vmax IT/VTI p) + 0.16
- Right ventriculo-arterial coupling measured by the TAPSE/PAPs ratio
- Tidal volume relative to theoretical ideal weight
- Adjusted external PEEP and total PEEP
- Driving pressure measured as plateau pressure minus total PEEP
- Respiratory system compliance measured as Vt/(Pplat - total PEEP)
- R/I ratio: recruitment-to-inflation ratio
- Airway opening pressure
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Jun 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing FascitisStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Santelys Association, HyperbaricCare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492030
- Sponsor's protocol ID
- 2025_0047
- Other IDs
- IDRCB
- Acronym
- SEPTICO2HBO
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Central Venous-arterial Carbon Dioxide Tension Difference to Diagnose Low Cardiac Output in Patients With Septic Shock Undergoing Hyperbaric Oxygen Therapy
- ClinicalTrials.gov ID
- NCT07492030
- Acronym / sponsor ID
- SEPTICO2HBO / 2025_0047
- Conditions
- Necrotizing Fascitis, Cellulitis, Septic Shock
- Keywords
- HBO, gapCO2, necrotizing fascitis, cellulitis, cardiac index
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Santelys Association, HyperbaricCare
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 25 Mar 2026 (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.
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.
Detailed description
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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients diagnosed with necrotizing fasciitis and receiving OHB | – | Other: EchographyAdult 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: * 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- - 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
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 |
|---|---|---|
| EchographyCardiac 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 | Other | Adult patients diagnosed with necrotizing fasciitis and receiving OHB |
Primary outcome
Area under the receiver operating characteristic (ROC) curve constructed from central venous-arterial carbon dioxide tension difference measurements
Time frame: After 15 minutes at maximum treatment pressure (T1)
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
4 secondary outcomes
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.
Time frame: 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Fascitis and Cellulitis, run by University Hospital, Lille at 1 site 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 5 inclusion and 15 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: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas DOGNON, Doctor (33 3 20 44 55 50, nicolas.dognon@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the receiver operating characteristic (ROC) curve constructed from central venous-arterial carbon dioxide tension difference measurements (time frame: After 15 minutes at maximum treatment pressure (T1)). 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 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.