The Utility of Pulse Pressure Variation to Predict the Fluid Responsiveness During Pneumoperitoneum and Reverse-Trendelenburg Position
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2016
CompletedFirst Posted
Study publicly available on registry
May 12, 2016
CompletedStudy Start
First participant enrolled
September 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2017
CompletedDecember 18, 2017
December 1, 2017
5 months
May 4, 2016
December 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pulse pressure variation
Ability of pulse pressure variation to predict fluid responsiveness will be evaluated.
During the surgery. At Day 0.
Study Arms (1)
Pulse pressure variation
EXPERIMENTALPulse pressure variation will be recorded via an arterial catheter after anesthetic induction, before pneumoperitoneum, after pneumoperitoneum, before infusion of 6% hydroxyethyl starch, and after infusion of 6% hydroxyethyl starch. Stroke volume will be also measured to differentiate the fluid responders.
Interventions
Fluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion.
Eligibility Criteria
You may qualify if:
- adult patients aged over 19 years who are scheduled for robotic or laparoscopic gastrectomy
You may not qualify if:
- cardiac arrhythmia
- valvular heart disease
- ischemic heart disease
- left ventricular ejection fraction less than 40%
- Pulmonary disease
- esophageal disease
- upper gastrointestinal bleeding
- Body mass index more than 40 kg/m2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University
Seoul, 120-752, South Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2016
First Posted
May 12, 2016
Study Start
September 29, 2016
Primary Completion
February 23, 2017
Study Completion
February 23, 2017
Last Updated
December 18, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share
The purpose of this study is to investigate the validity of pulse pressure variation to predict fluid responsiveness in patients undergoing robotic or laparoscopic gastrectomy.