General Anesthesia Induction for Elective SurgeryNCT02891772
Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
An observational study of General Anesthesia Induction for Elective Surgery, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- General Anesthesia Induction for Elective Surgery
- What is being tested?
- ultrasonographic measurement of corrected flow time(FTc) in carotid artery
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were scheduled to undergo elective surgery under general anesthesia
Who may be able to join
- adult patients (19-80 years of age) who were scheduled to undergo elective surgery under general anesthesia
Who cannot join
- 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
Show all 12Show fewer
- a left ventricular ejection fraction of < 40%
- severe vascular disease
- implanted pacemaker/cardioverter
- autonomic nervous system disorders
- anticipated difficult airway
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
Seoul, 03722
About this study
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.
- Being tested
- ultrasonographic measurement of corrected flow time(FTc) in carotid artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasonographic measurement of corrected flow time(FTc) in carotid arteryProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Hypotension after anesthetic induction group | Patients with hypotension after anesthetic induction Receives: Procedure: ultrasonographic measurement of corrected flow time(FTc) in carotid artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
corrected flow time (FTc) in carotid artery
the area under the receiver operating characteristics curve of corrected flow time in carotid artery measured by ultrasonography to predict hypotension after anesthetic induction
Measured: 10 minutes before induction of general anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: The investigator's workplace and department were changed so that the study could no longer be carried out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anesthesia Induction for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891772
- Sponsor's protocol ID
- 4-2016-0606
- Status last verified
- Jan 2019
- First submitted
- 31 Aug 2016
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Corrected Flow Time Measured by Ultrasonography as a Predictor of Hypotension After Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT02891772
- Acronym / sponsor ID
- 4-2016-0606
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The investigator's workplace and department were changed so that the study could no longer be carried out.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypotension after anesthetic induction group | – | Procedure: ultrasonographic measurement of corrected flow time(FTc) in carotid arteryPatients with hypotension after anesthetic induction |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were scheduled to undergo elective surgery under general anesthesia
Key inclusion criteria (1 listed)
- adult patients (19-80 years of age) who were scheduled to undergo elective surgery under general anesthesia
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasonographic measurement of corrected flow time(FTc) in carotid arteryCorrected 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. | Procedure or surgery | Hypotension after anesthetic induction group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia Induction for Elective Surgery, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corrected flow time (FTc) in carotid artery (time frame: 10 minutes before induction of general anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019.