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

NCT03914976 | Completed

• 2 other identifiers: 69HCL19_00412019-A00323-54
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications

Keywords

high-risk digestive surgery; intensive care unit

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

patient having to undergo a high risk programmed digestive surgery PROCEDURE

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)

patient who will have a high risk digestive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• 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.

  PMID: 35176527 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

It was estimated that there is between 40 and 60 ml of blood taken during this kind of intervention and in 24-hour postoperative intervention . The completion of the study should result in an increase in blood volume taken from 5 to 10 mL

Study Officials

• Mathieu GAZON

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: May 9, 2019
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: August 29, 2022

Record last verified: 2022-08

Locations

FR (1)