NCT05490147

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventilator Lung
• Liver Cirrhosis
• Hepatocellular Carcinoma
• Blood Loss, Surgical

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-08
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2022-08-05
• Last updated: 2022-08-05

Locations

1 site across 1 country: South Korea