Fluid ResponsivenessNCT06087250
Carotid Artery Corrected Flow Time and Fluid Responsiveness in Geriatric Patients
An observational study of Fluid Responsiveness and Common Carotid Artery, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Fluid Responsiveness, Common Carotid Artery
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 24 Oct 2023
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: geriatric patient (older than 65 years of age) having surgery under general anesthesia
Who may be able to join
- geriatric patient (older than 65 years of age) having surgery under general anesthesia
Who cannot join
- Common carotid artery stenosis, common carotid artery disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Carotid Artery Corrected Flow Time Predicting Fluid Responsiveness in Geriatric Patients.
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.
Read the detailed description
Doppler ultrasound of the common carotid artery has begun to be used as a potential non-invasive tool for assessing hemodynamic status. Its non-invasive nature, ability to be applied independently of the patient's position, ease of application due to the superficial location of the carotid artery, and resistance to intrathoracic pressure changes are among its advantages. 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. Additionally, the velocity time integral (VTI) measuring blood flow through the carotid artery during systole, when multiplied by the cross-sectional area of the carotid artery, allows for the determination of flow within the carotid artery. 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.
- Conditions
- Fluid Responsiveness, Common Carotid Artery
- Keywords
- fluid responsiveness, carotid blood flow, carotid corrected flow time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
carotid corrected flow time (cFT)
the ability ofc FT to predict fluid responsiveness
Measured: 1 hour
Secondary outcomes (1)
cutt-of value of cFT
the cutt-of value of cFT to predict fluid responsiveness
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 Aug 2023
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ResponsivenessStudies of the same condition, open and under way.
- 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beliz Bilgili, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087250
- Sponsor's protocol ID
- 2023
- Status last verified
- Apr 2024
- First submitted
- 12 Oct 2023
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Carotid Artery Corrected Flow Time Predicting Fluid Responsiveness in Geriatric Patients.
- ClinicalTrials.gov ID
- NCT06087250
- Acronym / sponsor ID
- 2023
- Conditions
- Fluid Responsiveness, Common Carotid Artery
- Keywords
- fluid responsiveness, carotid blood flow, carotid corrected flow time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 17 Oct 2023 (actual)
- 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.
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.
Detailed description
Doppler ultrasound of the common carotid artery has begun to be used as a potential non-invasive tool for assessing hemodynamic status. Its non-invasive nature, ability to be applied independently of the patient's position, ease of application due to the superficial location of the carotid artery, and resistance to intrathoracic pressure changes are among its advantages. 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. Additionally, the velocity time integral (VTI) measuring blood flow through the carotid artery during systole, when multiplied by the cross-sectional area of the carotid artery, allows for the determination of flow within the carotid artery. 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- geriatric patient (older than 65 years of age) having surgery under general anesthesia
Key inclusion criteria (1 listed)
- geriatric patient (older than 65 years of age) having surgery under general anesthesia
Key exclusion criteria (1 listed)
- Common carotid artery stenosis, common carotid artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
carotid corrected flow time (cFT)
Time frame: 1 hour
the ability ofc FT to predict fluid responsiveness
1 secondary outcome
cutt-of value of cFT
Time frame: 1 hour
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 2 Apr 2024.
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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 Fluid Responsiveness and Common Carotid Artery, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 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 2 Apr 2024. 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 Turkey (Türkiye). 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?
carotid corrected flow time (cFT) (time frame: 1 hour). 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 2 Apr 2024.