Clinical trial NCT03914976: Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication
Official title: Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Keywords: high-risk digestive surgery
intensive care unit
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: mean intraoperative PCO2 values
timeFrame: during surgery
measure: mean postoperative PCO2 values
timeFrame: within 24 hours after surgery
measure: post-operative complications
timeFrame: 28 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Mathieu GAZON
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.