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

August 3, 2022 updated by: Seoul National University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: during surgery
amount drained from peritoneal cavity - irrigation fluid
during surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 8, 2022

Primary Completion (ANTICIPATED)

August 8, 2023

Study Completion (ANTICIPATED)

August 8, 2023

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (ACTUAL)

August 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2206-069-1332

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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