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Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication

Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03914976
Acronym
CARBODAV
Enrollment
90
Registered
2019-04-16
Start date
2019-05-09
Completion date
2020-11-19
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery--Complications

Keywords

high-risk digestive surgery, intensive care unit

Brief summary

Intra-operative hemodynamic management in high-risk surgery is a priority for the anesthesiologist. The current strategy is based on the continuous measurement of cardiac output and its maximization by vascular filling has many limitations: invasiveness, measurement difficulties, impaired performance, imperative surgical restriction of filling, lack of evaluation of flow rate and metabolic needs. Biomarkers may be able to detect early an inadequacy between cardiac output and tissue oxygen requirements, venous saturation with oxygen (ScvO2) and arteriovenous difference in partial pressure of carbon dioxide (ΔPCO2) as well as the appearance of cellular hypoxia (lactate and arteriovenous difference in partial pressure of carbon dioxide/arteriovenous difference in oxygen) (ΔPCO2) / DAVO2). Moreover, the medical literature remains poor on the evaluation of these markers in per-operative context all the more for ΔPCO2 and ΔPCO2 / DAVO2. It seems interesting to evaluate the potential of these tools, in patients with major surgery and at high risk (major hepatectomy, oesophagectomy and duodeno-pancreatectomy), to predict the risk of postoperative complications, especially since surgery involves a restrictive vascular filling strategy that may be potentially deleterious to the patient.

Interventions

PROCEDUREpatient having to undergo a high risk programmed digestive surgery

The objective is to determine if there is an association between the mean intraoperative values and within 24 hours postoperative ΔPCO2 and the occurrence of major post-operative complications at day 28 in high-risk surgery (major hepatectomy, esophagectomy or duodeno- cephalic pancreatectomy)

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Major patient Patient eligible for a high risk scheduled gastrointestinal surgery from: * Esophagectomy * Major hepatectomy (≥ 3 segments) * Cephalic duodeno-pancreatectomy Patient with an arterial catheter and a central venous line in superior vena cava. Patient hospitalized post-operatively in intensive care unit as agreed in consultation with preoperative anesthesia.

Exclusion criteria

* Pregnant or lactating patients * Patient with an unstable acute condition at the time of surgery (acute heart, respiratory or renal failure, severe sepsis or septic shock, hemorrhagic shock) * Patient opposing his participation in the study * Patient protected by law (guardianship) * Patient deprived of liberty * Patient with a contraindication to the establishment of a central venous route in superior vena cava territory or a radial or femoral arterial catheter

Design outcomes

Primary

MeasureTime frameDescription
mean intraoperative PCO2 valuesduring surgeryPCO2 values will be collected every 2 hours during surgery
mean postoperative PCO2 valueswithin 24 hours after surgery
post-operative complications28 days after surgerypost-operative complications of grade III or greater according to Clavien-Dindo classification

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026