An observational study in Surgery--Complications, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Hospices Civils de Lyon · Observational
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.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's enrollment of 90 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.
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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
Major patient
Patient eligible for a high risk scheduled gastrointestinal surgery from:
Patient hospitalized post-operatively in intensive care unit as agreed in consultation with preoperative anesthesia.
Exclusion Criteria:
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)
mean intraoperative PCO2 values
PCO2 values will be collected every 2 hours during surgery
Time frame: during surgery
mean postoperative PCO2 values
Time frame: within 24 hours after surgery
post-operative complications
post-operative complications of grade III or greater according to Clavien-Dindo classification
Time frame: 28 days after surgery
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon