Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

NCT ID: NCT03399123

Last Updated: 2018-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-10-30

Brief Summary

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To explore the effect of low tidal volume on blood loss and gas exchange during laparoscopic hepatectomy

Detailed Description

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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

Conditions

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Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two different tidal volume are conducted on the participant base on the randomized choices
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Low tidal volume group

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

Group Type EXPERIMENTAL

Tidal volume

Intervention Type OTHER

After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.

Standard tidal volume group

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

Group Type ACTIVE_COMPARATOR

Tidal volume

Intervention Type OTHER

After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.

Interventions

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Tidal volume

After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Shuguo Zheng, MD

Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zheng ShuGuo

Role: PRINCIPAL_INVESTIGATOR

MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Locations

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Southwest Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ning Jiaolin

Role: CONTACT

0086-15808014085

Facility Contacts

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Ning Jiaolin

Role: primary

0086-15808014085

Other Identifiers

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MZK001

Identifier Type: -

Identifier Source: org_study_id

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