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Trial Title:
Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy
NCT ID:
NCT05490147
Condition:
Ventilator Lung
Liver Cirrhosis
Hepatocellular Carcinoma
Blood Loss, Surgical
Conditions: Official terms:
Liver Cirrhosis
Blood Loss, Surgical
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
a surgeon blinded randomized controlled study
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Procedure
Intervention name:
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
Description:
In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]=
ideal body weight [kg]* 10~12.
Arm group label:
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
Intervention type:
Procedure
Intervention name:
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Description:
In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal
body weight [kg]* 6~8.
Arm group label:
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
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.
Criteria for eligibility:
Criteria:
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:
All
Minimum age:
19 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Start date:
August 8, 2022
Completion date:
August 8, 2023
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490147