- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02891772
Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
January 14, 2019 updated by: Yonsei University
Hypotension often happens immediately after anesthetic induction.
Particularly in 5-10 minutes after anesthetic induction it is reported to happen more frequently.
Patients may have preexisting hypovolemia resulting from dehydration and impaired compensatory responses, which increase the risk.
However, it is still challenging to assess intravascular volume status in spontaneously breathing patients before anesthetic induction.
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.
The aim of this study is to evaluate whether corrected carotid artery flow time as determined by ultrasonography in spontaneously breathing patients before general anesthesia can predict hypotension after induction.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 03722
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who were scheduled to undergo elective surgery under general anesthesia
Description
Inclusion Criteria:
• adult patients (19-80 years of age) who were scheduled to undergo elective surgery under general anesthesia
Exclusion Criteria:
- mean blood pressure < 70 mmHg before induction of general anesthesia
- Patients who have currently taken angiotensin-converting enzyme inhibitor
- Patients who have currently taken angiotensin receptor blocker
- the presence of carotid artery stenosis > 50%
- cardiac rhythm other than sinus
- unstable angina
- a left ventricular ejection fraction of < 40%
- severe vascular disease
- implanted pacemaker/cardioverter
- autonomic nervous system disorders
- anticipated difficult airway
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hypotension after anesthetic induction group
Patients with hypotension after anesthetic induction
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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.
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).
The blood pressure was taken before anesthetic induction and every two minutes after anesthetic induction till ten minutes after endotracheal intubation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
corrected flow time (FTc) in carotid artery
Time Frame: 10 minutes before induction of general anesthesia.
|
the area under the receiver operating characteristics curve of corrected flow time in carotid artery measured by ultrasonography to predict hypotension after anesthetic induction
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10 minutes before induction of general anesthesia.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Anticipated)
August 1, 2017
Study Completion (Anticipated)
August 1, 2017
Study Registration Dates
First Submitted
August 31, 2016
First Submitted That Met QC Criteria
August 31, 2016
First Posted (Estimate)
September 7, 2016
Study Record Updates
Last Update Posted (Actual)
January 16, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2016-0606
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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