NCT06087250

Brief Summary

Carotid blood flow and corrected carotid flow time (Carotid Flow Time (FTc)) provide information about left ventricular preload and inversely correlate with systemic vascular resistance. The reliability in assessing fluid responsiveness has been demonstrated in studies involving invasive cardiac output measurements. In the elderly patient population where arterial elasticity can be compromised, there is no existing data in literature that determines the reliability and predictive value of FTc after general anesthesia induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2023

Completed
Last Updated

April 2, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

October 12, 2023

Last Update Submit

April 1, 2024

Conditions

Fluid ResponsivenessCommon Carotid Artery

Keywords

fluid responsivenesscarotid blood flowcarotid corrected flow time

Outcome Measures

Primary Outcomes (1)

  • carotid corrected flow time (cFT)

    the ability ofc FT to predict fluid responsiveness

    1 hour

Secondary Outcomes (1)

  • cutt-of value of cFT

    1 hour

Study Arms (2)

Fluid responsive

A 15% increase in cardiac output following a fluid challenge ( 6ml/kg crystalloid solution infusion in 30 min). Carotid corrected flow time measured before and after fluid challenge by ultrasound.

Fluid non-responsive

Failure of 15% increase in cardiac output following a fluid challenge ( 6ml/kg crystalloid solution infusion in 30 min). Carotid corrected flow time measured before and after fluid challenge by ultrasound.

Eligibility Criteria

Age65 Years - 100 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsolder than 65 years of age
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

geriatric patient (older than 65 years of age) having surgery under general anesthesia

You may qualify if:

  • geriatric patient (older than 65 years of age) having surgery under general anesthesia

You may not qualify if:

  • Common carotid artery stenosis, common carotid artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Prof, M.D

Study Record Dates

First Submitted

October 12, 2023

First Posted

October 17, 2023

Study Start

August 1, 2023

Primary Completion

October 24, 2023

Study Completion

October 24, 2023

Last Updated

April 2, 2024

Record last verified: 2024-04

Locations

TU(1)