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Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

Primary Purpose

Blood Loss

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tidal volume
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Blood Loss focused on measuring Laparoscopic hepatectomy, Low tidal volume, Blood loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged from 18 to 70 years old;
  2. American association of anesthesiologists(ASA) score I to III;
  3. Ability to adhere to the study schedule;
  4. Ability to provide informed consent and complete all study assessments;
  5. Patients undergoing selective surgery of laparoscopic hepatectomy.

Exclusion Criteria:

  1. The New York Heart Association classification(NYHA) III to IV;
  2. Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery.
  3. BMI>32Kg/m2;
  4. Abnormal in blood coagulation function;
  5. Patients with mental disease;
  6. Patients with neuromuscular disease;
  7. Concurrent enrollment in another Randomized controlled trial(RCT);
  8. Absence of written informed consent.

Sites / Locations

  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low tidal volume group

Standard tidal volume group

Arm Description

Use a low tidal volume(6'8ml/kg) ventilation mode during liver segmentation。

Use a standard tidal volume(10'12ml/kg) ventilation mode during operation.

Outcomes

Primary Outcome Measures

Blood loss
Blood loss during operation.

Secondary Outcome Measures

central venous pressure
The central venous pressure(CVP)during operation
mean arterial pressure
The mean arterial pressure(MAP)during operation
oxygenation index
The oxygenation index during operation.

Full Information

First Posted
January 4, 2018
Last Updated
January 11, 2018
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03399123
Brief Title
Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
Official Title
Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
October 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

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
To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy
Detailed Description
Background & Aims:Liver cancer is an disease that threatening human health .Laparoscopic hepatectomy is more and more widely used.It is very important to reduce the bleeding during laparoscopic hepatectomy.The investigators found that low tidal volume can effectively reduce intraoperative bleeding.The aim of this study was to explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
Laparoscopic hepatectomy, Low tidal volume, Blood loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two different tidal volume are conducted on the participant base on the randomized choices
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low tidal volume group
Arm Type
Experimental
Arm Description
Use a low tidal volume(6'8ml/kg) ventilation mode during liver segmentation。
Arm Title
Standard tidal volume group
Arm Type
Active Comparator
Arm Description
Use a standard tidal volume(10'12ml/kg) ventilation mode during operation.
Intervention Type
Other
Intervention Name(s)
Tidal volume
Intervention Description
After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.
Primary Outcome Measure Information:
Title
Blood loss
Description
Blood loss during operation.
Time Frame
through study completion, an average of 48hours
Secondary Outcome Measure Information:
Title
central venous pressure
Description
The central venous pressure(CVP)during operation
Time Frame
During operation
Title
mean arterial pressure
Description
The mean arterial pressure(MAP)during operation
Time Frame
During operation
Title
oxygenation index
Description
The oxygenation index during operation.
Time Frame
During operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged from 18 to 70 years old; American association of anesthesiologists(ASA) score I to III; Ability to adhere to the study schedule; Ability to provide informed consent and complete all study assessments; Patients undergoing selective surgery of laparoscopic hepatectomy. Exclusion Criteria: The New York Heart Association classification(NYHA) III to IV; Chronic obstructive pulmonary disease,respiratory failure, patients after thoracic surgery. BMI>32Kg/m2; Abnormal in blood coagulation function; Patients with mental disease; Patients with neuromuscular disease; Concurrent enrollment in another Randomized controlled trial(RCT); Absence of written informed consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning Jiaolin
Phone
0086-15808014085
Email
Njiaolin1976@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zheng ShuGuo
Organizational Affiliation
MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ning Jiaolin
Phone
0086-15808014085
Email
Njiaolin1976@126.com

12. IPD Sharing Statement

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Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

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