NCT02843477

Brief Summary

It is still challenging to assess intravascular volume status in spontaneously breathing patients. Recently, the measurement of corrected flow time in carotid artery was introduced as quite useful, simple and noninvasive for the evaluation of circulating blood volume change. The aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography can be a predictor of fluid responsiveness in spontaneously breathing patients before induction of general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Shorter than P25 for all trials

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

July 21, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

August 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

7 months

First QC Date

July 21, 2016

Last Update Submit

July 15, 2018

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (2)

  • ultrasonographic measurement of corrected flow time in carotid artery

    The ultrasonographic measurement of corrected flow time in carotid artery will be performed before fluid loading.

    right before fluid loading

  • ultrasonographic measurement of corrected flow time in carotid artery

    The ultrasonographic measurement of corrected flow time in carotid artery will be performed 5 minutes after fluid loading.

    5 minutes after fluid loading

Study Arms (1)

Fluid loading group

Spontaneously breathing patients before induction of general anesthesia who receive fluid loading

Device: ultrasonographic measurement of corrected flow time in carotid artery

Interventions

ultrasonographic measurement of corrected flow time in carotid arteryDEVICE

Corrected carotid artery flow time is measured using 10-5 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed while the Doppler beams were adjusted to ensure \< 60° of angle for the best signal. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).

Fluid loading group

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who were scheduled to undergo elective neurosurgery for brain tumor

You may qualify if:

  • adult patients (19-80 years of age) who were scheduled to undergo elective neurosurgery for brain tumor

You may not qualify if:

  • BMI \> 35 or \< 15 kg/m2
  • the presence of carotid artery stenosis \> 50%
  • systolic blood pressure \> 160 mmHg
  • cardiac rhythm other than sinus
  • intracardiac shunt 6. valvular heart disease
  • a left ventricular ejection fraction of \< 50%
  • right ventricular dysfunction 9
  • chronic obstructive pulmonary disease
  • pulmonary hypertension
  • chronic kidney disease (eGFR \< 60 mL/min/1.73m2)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Seoul, 03722, South Korea

Location

Related Publications (1)

  • Kim DH, Shin S, Kim N, Choi T, Choi SH, Choi YS. Carotid ultrasound measurements for assessing fluid responsiveness in spontaneously breathing patients: corrected flow time and respirophasic variation in blood flow peak velocity. Br J Anaesth. 2018 Sep;121(3):541-549. doi: 10.1016/j.bja.2017.12.047. Epub 2018 Apr 12.

    PMID: 30115251DERIVED

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

July 25, 2016

Study Start

August 9, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)