Effect of Low Tidal Volume on Blood Loss During Laparoscopic Hepatectomy

NCT03399123 | Unknown DMC

• 1 other identifier: MZK001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Loss

Keywords

Laparoscopic hepatectomy; Low tidal volume; Blood loss

Outcome Measures

Primary Outcomes (1)

• Blood loss

  Blood loss during operation.

  through study completion, an average of 48hours

Secondary Outcomes (3)

• central venous pressure

  During operation

• mean arterial pressure

  During operation

• oxygenation index

  During operation

Study Arms (2)

Low tidal volume group

EXPERIMENTAL

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

Other: Tidal volume

Standard tidal volume group

ACTIVE COMPARATOR

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

Other: Tidal volume

Interventions

Tidal volume OTHER

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

Low tidal volume group; Standard tidal volume group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southwest Hospital, China: lead

Study Sites (1)

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Tidal Volume

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Inspiratory Capacity; Vital Capacity; Total Lung Capacity; Lung Volume Measurements; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Zheng ShuGuo

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Jiaolin

CONTACT

0086-15808014085; Njiaolin1976@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University Affiliation: Southwest Hospital, China

Model Details: Two different tidal volume are conducted on the participant base on the randomized choices

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 16, 2018
• Study Start: April 1, 2017
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: January 16, 2018

Record last verified: 2018-01

Locations

CN (1)