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Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

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ClinicalTrials.gov Identifier: NCT03399123
Recruitment Status : Recruiting
First Posted : January 16, 2018
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Shuguo Zheng, MD, Southwest Hospital, China

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

Condition or disease Intervention/treatment Phase
Blood Loss Other: Tidal volume Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two different tidal volume are conducted on the participant base on the randomized choices
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Low tidal volume group
Use a low tidal volume(6`8ml/kg) ventilation mode during liver segmentation。
Other: Tidal volume
After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.

Active Comparator: Standard tidal volume group
Use a standard tidal volume(10`12ml/kg) ventilation mode during operation.
Other: Tidal volume
After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.




Primary Outcome Measures :
  1. Blood loss [ Time Frame: through study completion, an average of 48hours ]
    Blood loss during operation.


Secondary Outcome Measures :
  1. central venous pressure [ Time Frame: During operation ]
    The central venous pressure(CVP)during operation

  2. mean arterial pressure [ Time Frame: During operation ]
    The mean arterial pressure(MAP)during operation

  3. oxygenation index [ Time Frame: During operation ]
    The oxygenation index during operation.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399123


Contacts
Contact: Ning Jiaolin 0086-15808014085 Njiaolin1976@126.com

Locations
China, Chongqing
Southwest Hospital Recruiting
Chongqing, Chongqing, China, 400038
Contact: Ning Jiaolin    0086-15808014085    Njiaolin1976@126.com   
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Principal Investigator: Zheng ShuGuo MD Study Director Institute of Hepatobiliary Surgery ,Southwest Hospital ,Third Military Medical University

Responsible Party: Shuguo Zheng, MD, Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT03399123     History of Changes
Other Study ID Numbers: MZK001
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shuguo Zheng, MD, Southwest Hospital, China:
Laparoscopic hepatectomy
Low tidal volume
Blood loss

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes