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Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia

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ClinicalTrials.gov Identifier: NCT02891772
Recruitment Status : Withdrawn (The investigator's workplace and department were changed so that the study could no longer be carried out.)
First Posted : September 7, 2016
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date August 31, 2016
First Posted Date September 7, 2016
Last Update Posted Date January 16, 2019
Study Start Date August 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2016)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
Official Title Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who were scheduled to undergo elective surgery under general anesthesia
Condition General Anesthesia Induction for Elective Surgery
Intervention Procedure: ultrasonographic measurement of corrected flow time(FTc) in carotid artery
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.
Study Groups/Cohorts Hypotension after anesthetic induction group
Patients with hypotension after anesthetic induction
Intervention: Procedure: ultrasonographic measurement of corrected flow time(FTc) in carotid artery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: January 14, 2019)
0
Original Estimated Enrollment
 (submitted: August 31, 2016)
94
Estimated Study Completion Date August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02891772
Other Study ID Numbers 4-2016-0606
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date January 2019