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

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.

Study Overview

• Status: Completed
• Conditions: Surgery--Complications
• Intervention / Treatment: Procedure: patient having to undergo a high risk programmed digestive surgery

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hopital de la croix rousse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study concerns patients operated for a high-risk digestive surgery, hospitalized postoperatively in intensive care unit (agreed in anesthesia consultation). These patients will also need to have an arterial catheter and a central venous line in the superior vena cava

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient who will have a high risk digestive surgery; patient who will have a high risk digestive surgery: esophagectomy, major hepatectomy> 3 segments, duodeno cephalic pancreatectomy	Procedure: patient 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean intraoperative PCO2 values	PCO2 values will be collected every 2 hours during surgery	during surgery
mean postoperative PCO2 values		within 24 hours after surgery
post-operative complications	post-operative complications of grade III or greater according to Clavien-Dindo classification	28 days after surgery

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Mathieu GAZON, Hospices Civils de Lyon

Publications and helpful links

General Publications

• Guilherme E, Delignette MC, Pambet H, Lebreton T, Bonnet A, Pradat P, Boucheny C, Guichon C, Aubrun F, Gazon M. PCO2 gap, its ratio to arteriovenous oxygen content, ScvO2 and lactate in high-risk abdominal surgery patients: An observational study. Anaesth Crit Care Pain Med. 2022 Apr;41(2):101033. doi: 10.1016/j.accpm.2022.101033. Epub 2022 Feb 14.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2019
• Primary Completion (ACTUAL): November 19, 2020
• Study Completion (ACTUAL): November 19, 2020

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; high-risk digestive surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: 69HCL19_0041; 2019-A00323-54 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No