Brain TumorNCT02843477
Evaluation of Corrected Carotid Artery Flow Time as a Predictor of Fluid Responsiveness in Spontaneous Breathing Patients
An observational study of Brain Tumor, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- ultrasonographic measurement of corrected flow time in carotid artery
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Aug 2016to 28 Feb 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 neurosurgery for brain tumor
Who may be able to join
- adult patients (19-80 years of age) who were scheduled to undergo elective neurosurgery for brain tumor
Who cannot join
- 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%
Show all 11Show fewer
- right ventricular dysfunction 9
- chronic obstructive pulmonary disease
- pulmonary hypertension
- chronic kidney disease (eGFR < 60 mL/min/1.73m2)
- 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
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.
- Conditions
- Brain Tumor
- Being tested
- ultrasonographic measurement of corrected flow time in carotid artery
- Medical subject headings
- Brain Neoplasms
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 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).
| Study group | Role | What they receive |
|---|---|---|
| Fluid loading group | Spontaneously breathing patients before induction of general anesthesia who receive fluid loading Receives: Device: ultrasonographic measurement of corrected flow time in carotid artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 minutes after fluid loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study start9 Aug 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies 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
- 54 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
- NCT02843477
- Sponsor's protocol ID
- 4-2016-0426
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 30115251
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corrected Carotid Artery Flow Time as a Predictor of Fluid Responsiveness in Spontaneous Breathing Patients
- ClinicalTrials.gov ID
- NCT02843477
- Acronym / sponsor ID
- 4-2016-0426
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 9 Aug 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 25 Jul 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluid loading group | – | Device: ultrasonographic measurement of corrected flow time in carotid arterySpontaneously breathing patients before induction of general anesthesia who receive fluid loading |
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 neurosurgery for brain tumor
Key inclusion criteria (1 listed)
- adult patients (19-80 years of age) who were scheduled to undergo elective neurosurgery for brain tumor
Key exclusion criteria (11 listed)
- 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
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 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 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). | Device | Fluid loading group |
Primary outcome
ultrasonographic measurement of corrected flow time in carotid artery
Time frame: right before fluid loading
The ultrasonographic measurement of corrected flow time in carotid artery will be performed before fluid loading.
ultrasonographic measurement of corrected flow time in carotid artery
Time frame: 5 minutes after fluid loading
The ultrasonographic measurement of corrected flow time in carotid artery will be performed 5 minutes after fluid loading.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 30115251Kim 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.
- 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 Brain Tumor, 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 11 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: finished, as of the sponsor's last update on 17 Jul 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ultrasonographic measurement of corrected flow time in carotid artery (time frame: right before fluid loading). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843477, which also lists 1 linked publication.
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 17 Jul 2018.