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

Not Applicable

• Conditions: Blood Loss, Surgical; Hepatocellular Carcinoma; Ventilator Lung; Liver Cirrhosis
• Interventions: Procedure: low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume; Procedure: conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

• Registration Number: NCT05490147
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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.

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-31
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-05
• Last Update Posted: 2022-08-05
• Study Start: 2022-08-08
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume	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.
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group	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.

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	during surgery	amount drained from peritoneal cavity - irrigation fluid

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of