Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy

Overview

This randomized controlled study's objective is to find a safer mechanical ventilation strategy to reduce intraoperative bleeding in liver cancer patients undergoing laparoscopic major liver resection. The hypothesis is that low tidal volume ventilation in laparoscopic major hepatectomy results in less bleeding.

Full Title of Study: “Effect of Low Tidal Volume Ventilation Strategy Combined Goal -Directed Fluid Therapy on Intraoperative Bleeding Undergoing Laparoscopic Major Hepatectomy in Liver Cancer Patients: a Surgeon Blinded Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: August 8, 2023

Detailed Description

Patients are randomized into the conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group and low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume group and ventilated accordingly throughout the surgery. All patients undergo general anesthesia with propofol, remifentanil, and rocuronium and are intubated with an endotracheal tube (ID 7.0 for females, ID 7.5 for males). Anesthesia is maintained with sevoflurane, end tidal CO2 is targeted between 30-35mmHg. The radial artery is cannulated and connected to the Flotrac sensor and goal directed fluid therapy is done. The estimated blood loss is checked as the primary outcome. In addition postoperative complications, transfusion amounts, operation time, satisfaction of the surgeon and participants are also recorded.

Interventions

  • Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
    • In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12.
  • Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
    • In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8.

Arms, Groups and Cohorts

  • Experimental: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
    • In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12 throughout the surgery.
  • Experimental: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
    • In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8 throughout the surgery.

Clinical Trial Outcome Measures

Primary Measures

  • Intraoperative blood loss
    • Time Frame: during surgery
    • amount drained from peritoneal cavity – irrigation fluid

Secondary Measures

  • postoperative lung complications
    • Time Frame: op end ~ postoperative 2 weeks
    • atelectasis, pneumonia
  • transfusion amount
    • Time Frame: op. end ~ postoperative day 3
    • RBC, FFP, platelet
  • postoperative hemoglobin level
    • Time Frame: op. end ~ postoperative day 3
    • postoperative hemoglobin
  • postoperative total bilirubin level
    • Time Frame: op. end ~ postoperative day 3
    • postoperative total bilirubin level
  • postoperative PT INR level
    • Time Frame: op. end ~ postoperative day 3
    • postoperative PT INR level
  • postoperative aspartate aminotransferase level
    • Time Frame: op. end ~ postoperative day 3
    • postoperative aspartate aminotransferase level
  • postoperative alanine aminotransferase level
    • Time Frame: op. end ~ postoperative day 3
    • postoperative alanine aminotransferase level
  • postoperative serum creatinine level
    • Time Frame: op. end ~ postoperative day 3
    • postoperative serum creatinine level
  • operation time
    • Time Frame: during surgery
    • operation time
  • amount of crystalloids infused
    • Time Frame: during surgery
    • amount of crystalloids infused
  • Satisfaction scale of the operator and participants
    • Time Frame: during surgery
    • easy 0 – 10 difficult

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with hepatocellular carcinoma scheduled for laparoscopic major hepatectomy, defined as resection of more than 30% of non-anatomical resection or more than 3 segments Exclusion Criteria:

  • ASA class >4 – patients with chronic obstructive pulmonary disease – patients with Child-Pugh score C – patients with arrythmia

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seong Mi Yang, Principal Investigator, Seoul National University Hospital
  • Overall Contact(s)
    • Seong Mi Yang, +82-10-7300-6282, seongmi.yang@gmail.com

References

Hendi M, Lv J, Cai XJ. Current status of laparoscopic hepatectomy for the treatment of hepatocellular carcinoma: A systematic literature review. Medicine (Baltimore). 2021 Dec 17;100(50):e27826. doi: 10.1097/MD.0000000000027826.

Nomi T, Fuks D, Govindasamy M, Mal F, Nakajima Y, Gayet B. Risk factors for complications after laparoscopic major hepatectomy. Br J Surg. 2015 Feb;102(3):254-60. doi: 10.1002/bjs.9726. Epub 2014 Dec 17.

Jones RM, Moulton CE, Hardy KJ. Central venous pressure and its effect on blood loss during liver resection. Br J Surg. 1998 Aug;85(8):1058-60.

Kobayashi S, Honda G, Kurata M, Tadano S, Sakamoto K, Okuda Y, Abe K. An Experimental Study on the Relationship Among Airway Pressure, Pneumoperitoneum Pressure, and Central Venous Pressure in Pure Laparoscopic Hepatectomy. Ann Surg. 2016 Jun;263(6):1159-63. doi: 10.1097/SLA.0000000000001482.

Gao X, Xiong Y, Huang J, Zhang N, Li J, Zheng S, Lu K, Ma D, Yang B, Ning J. The Effect of Mechanical Ventilation With Low Tidal Volume on Blood Loss During Laparoscopic Liver Resection: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1033-1041. doi: 10.1213/ANE.0000000000005242.

Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f.

Dunki-Jacobs EM, Philips P, Scoggins CR, McMasters KM, Martin RC 2nd. Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring. Ann Surg Oncol. 2014 Feb;21(2):473-8. doi: 10.1245/s10434-013-3323-9. Epub 2013 Oct 23.

Correa-Gallego C, Tan KS, Arslan-Carlon V, Gonen M, Denis SC, Langdon-Embry L, Grant F, Kingham TP, DeMatteo RP, Allen PJ, D'Angelica MI, Jarnagin WR, Fischer M. Goal-Directed Fluid Therapy Using Stroke Volume Variation for Resuscitation after Low Central Venous Pressure-Assisted Liver Resection: A Randomized Clinical Trial. J Am Coll Surg. 2015 Aug;221(2):591-601. doi: 10.1016/j.jamcollsurg.2015.03.050. Epub 2015 Apr 7.

Ratti F, Cipriani F, Reineke R, Catena M, Paganelli M, Comotti L, Beretta L, Aldrighetti L. Intraoperative monitoring of stroke volume variation versus central venous pressure in laparoscopic liver surgery: a randomized prospective comparative trial. HPB (Oxford). 2016 Feb;18(2):136-144. doi: 10.1016/j.hpb.2015.09.005. Epub 2015 Nov 17.

Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

Serpa Neto A, Schultz MJ, Gama de Abreu M. Intraoperative ventilation strategies to prevent postoperative pulmonary complications: Systematic review, meta-analysis, and trial sequential analysis. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):331-40. doi: 10.1016/j.bpa.2015.09.002. Epub 2015 Sep 18. Review.

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