Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

Not Applicable

• Conditions: Blood Loss
• Interventions: Other: Tidal volume

• Registration Number: NCT03399123
• Lead Sponsor: Southwest Hospital, China

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

Study Timeline

• Study Start: 2017-04-01
• Status Verified: 2018-01
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Study First Posted: 2018-01-16
• Last Update Posted: 2018-01-16
• Primary Completion: 2018-10-30
• Study Completion: 2018-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low tidal volume group	Tidal volume	Use a low tidal volume(6'8ml/kg) ventilation mode during liver segmentation。
Standard tidal volume group	Tidal volume	Use a standard tidal volume(10'12ml/kg) ventilation mode during operation.

Primary Outcome Measures

Name	Time	Method
Blood loss	through study completion, an average of 48hours	Blood loss during operation.

Secondary Outcome Measures

Name	Time	Method
mean arterial pressure	During operation	The mean arterial pressure(MAP)during operation
oxygenation index	During operation	The oxygenation index during operation.
central venous pressure	During operation	The central venous pressure(CVP)during operation

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China