NCT02771067

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 12, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2017

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

May 4, 2016

Last Update Submit

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

EXPERIMENTAL

Pulse 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.

Procedure: Fluid infusion

Interventions

Fluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion.

Pulse pressure variation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Locations