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

Primary Purpose

Ventilator Lung, Liver Cirrhosis, Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Lung

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group

low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume

Arm Description

In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12 throughout the surgery.

In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8 throughout the surgery.

Outcomes

Primary Outcome Measures

Intraoperative blood loss
amount drained from peritoneal cavity - irrigation fluid

Secondary Outcome Measures

postoperative lung complications
atelectasis, pneumonia
transfusion amount
RBC, FFP, platelet
postoperative hemoglobin level
postoperative hemoglobin
postoperative total bilirubin level
postoperative total bilirubin level
postoperative PT INR level
postoperative PT INR level
postoperative aspartate aminotransferase level
postoperative aspartate aminotransferase level
postoperative alanine aminotransferase level
postoperative alanine aminotransferase level
postoperative serum creatinine level
postoperative serum creatinine level
operation time
operation time
amount of crystalloids infused
amount of crystalloids infused
Satisfaction scale of the operator and participants
easy 0 - 10 difficult

Full Information

First Posted
July 31, 2022
Last Updated
August 3, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05490147
Brief Title
Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy
Official Title
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
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 8, 2022 (Anticipated)
Primary Completion Date
August 8, 2023 (Anticipated)
Study Completion Date
August 8, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Lung, Liver Cirrhosis, Hepatocellular Carcinoma, Blood Loss, Surgical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a surgeon blinded randomized controlled study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
Arm Type
Experimental
Arm Description
In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12 throughout the surgery.
Arm Title
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Arm Type
Experimental
Arm Description
In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8 throughout the surgery.
Intervention Type
Procedure
Intervention Name(s)
conventional tidal volume (tidal volume [ml]= ideal body weight [kg]* 10~12) group
Intervention Description
In the conventional tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 10~12.
Intervention Type
Procedure
Intervention Name(s)
low tidal (tidal volume [ml]= ideal body weight [kg] * 6~8) volume
Intervention Description
In the low tidal volume group, patients are ventilated with a tidal volume [ml]= ideal body weight [kg]* 6~8.
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
amount drained from peritoneal cavity - irrigation fluid
Time Frame
during surgery
Secondary Outcome Measure Information:
Title
postoperative lung complications
Description
atelectasis, pneumonia
Time Frame
op end ~ postoperative 2 weeks
Title
transfusion amount
Description
RBC, FFP, platelet
Time Frame
op. end ~ postoperative day 3
Title
postoperative hemoglobin level
Description
postoperative hemoglobin
Time Frame
op. end ~ postoperative day 3
Title
postoperative total bilirubin level
Description
postoperative total bilirubin level
Time Frame
op. end ~ postoperative day 3
Title
postoperative PT INR level
Description
postoperative PT INR level
Time Frame
op. end ~ postoperative day 3
Title
postoperative aspartate aminotransferase level
Description
postoperative aspartate aminotransferase level
Time Frame
op. end ~ postoperative day 3
Title
postoperative alanine aminotransferase level
Description
postoperative alanine aminotransferase level
Time Frame
op. end ~ postoperative day 3
Title
postoperative serum creatinine level
Description
postoperative serum creatinine level
Time Frame
op. end ~ postoperative day 3
Title
operation time
Description
operation time
Time Frame
during surgery
Title
amount of crystalloids infused
Description
amount of crystalloids infused
Time Frame
during surgery
Title
Satisfaction scale of the operator and participants
Description
easy 0 - 10 difficult
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seong Mi Yang
Phone
+82-10-7300-6282
Email
seongmi.yang@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hye-Yeon Cho
Email
bdbd7799@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Mi Yang
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
34918631
Citation
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Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
9717995
Citation
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. doi: 10.1046/j.1365-2168.1998.00795.x.
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
33060490
Citation
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Results Reference
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PubMed Identifier
19300227
Citation
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Effect of Low Tidal Ventilation on Intraoperative Bleeding in Laparoscopic Major Hepatectomy

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