Flow TimeNCT05896514
Carotis cFT In Prediction Of Hypotension
An observational study of Flow Time and Carotid Doppler Ultrasound, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to determine the predictive value of pre-anesthesia FTc for hypotension that may develop after general anesthesia induction in patients over 65 years of age and to investigate the correlation between pre-anesthesia FTc and the magnitude of the maximum decrease in systolic blood pressure from… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Flow Time, Carotid Doppler Ultrasound, Hypotension
- What is being tested?
- ultrasound-guided carotid artery flow time measurement
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2023to 7 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients > 65 years old who will undergo elective surgery under general anesthesia will be include in the study. In the preoperative unit, the FTc value in B-mode will be measured under ultrasound guidance (Esaote, MyLab tm Six Ultrasound). After the measurement, in the operating room the patients will be monitored with 3-lead electrocardiography, pulse oximetry, and noninvasive blood pressure (Infinity Kappa monitor, GE Medical Systems, Inc, Telford, PA). Before induction of anesthesia, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) and heart rate will be measured for 3 minutes at 1-minute intervals. Anesthesia induction will be achieved with iv 1-2 mg/kg of propofol and iv 0.6 mg/kg rocuronium will be added for muscle relaxation.Sevoflurane 1-2% and 50-50% oxygen-nitrous oxide will be used during mask ventilation. After anesthesia induction, SBP, DBP, MAP and heart rate will be measured for 3 minutes at 1-minute intervals.
Who may be able to join
- >65 years old
- undergoing elective surgery under general anesthesia
Who cannot join
- Mean arterial pressure < 70 mmHg
- Systolic blood pressure > 180 mmHg
- Diastolic blood pressure > 110 mmHg
- < 65 years old
- Carotid artery stenosis > 50%
- ASA > 3
Show all 13Show fewer
- Left ventricle ejection fraction < 40%
- Severe peripheral vascular disease
- Implanted pacemacer
- Autonomic nervous system disorders
- Heart valve disease
- Chronic kidney disease
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Carotis Flow Time in Prediction of Hypotension After Anesthesia Induction in Elderly Patients
The aim of our study is to determine the predictive value of pre-anesthesia FTc for hypotension that may develop after general anesthesia induction in patients over 65 years of age and to investigate the correlation between pre-anesthesia FTc and the magnitude of the maximum decrease in systolic blood pressure from the pre-anaesthetic value.
Read the detailed description
The FTc value of the patients to be included in the study will be measured by ultrasonography 10 minutes before the induction of anesthesia.After the measurement, the patients will be monitored with 3-lead electrocardiography, pulse oximetry and noninvasive blood pressure in the operating room. Before induction of general anesthesia, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), oxygen saturation and heart rate will measured for 3 minutes at 1-minute intervals. Induction of anesthesia with 1-2 mg/kg propofol, muscle relaxation will be achieved with 0.6 mg/kg intravenous rocuronium. During mask ventilation, 1-2% concentration of sevoflurane and 50-50% oxygen-nitrous oxide will be used. After the anesthesia induction, SBP, DBP, MAP, oxygen saturation and heart rate will be measured for 3 minutes at 1-minute intervals.
Hypotension; defined as a 30% reduction in SBP or a 20% reduction in MAP, or an absolute SBP below 90 mm Hg and MAP below 65 mm Hg within 3 minutes of induction of general anesthesia.Intravenous (iv) noradrenaline and/or iv crystalloid will be used in the treatment of hypotension.
- Conditions
- Flow Time, Carotid Doppler Ultrasound, Hypotension, Anesthesia, Elderly
- Being tested
- ultrasound-guided carotid artery flow time measurement
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided carotid artery flow time measurementDevice
Ultrasound-guided corrected carotid artery flow time will be measured before anestesia induction.
What is being measured
The primary outcome is the main question the study is designed to answer.
anesthesia induction related hypotension
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) were measured 1 minute before anesthesia induction and after anesthesia induction (at 1 minute intervals for 3 minutes). Hypotension was defined as 30% decrease in SBP or a 20% decrease in MAP or absolute SBP less than 90 mm Hg, and MAP below 65 mm Hg within 3 minutes of induction of general anaesthesia.
Measured: at 1 minute after anesthesia induction, at 2 minutes after anesthesia induction, at 3 minutes anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start3 Jun 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flow TimeStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mediha turktan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896514
- Sponsor's protocol ID
- Carotid cFT
- Status last verified
- Dec 2023
- First submitted
- 31 May 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Carotis Flow Time in Prediction of Hypotension After Anesthesia Induction in Elderly Patients
- ClinicalTrials.gov ID
- NCT05896514
- Acronym / sponsor ID
- Carotid cFT
- Conditions
- Flow Time, Carotid Doppler Ultrasound, Hypotension, Anesthesia, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 3 Jun 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 9 Jun 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.
The aim of our study is to determine the predictive value of pre-anesthesia FTc for hypotension that may develop after general anesthesia induction in patients over 65 years of age and to investigate the correlation between pre-anesthesia FTc and the magnitude of the maximum decrease in systolic blood pressure from the pre-anaesthetic value.
Detailed description
The FTc value of the patients to be included in the study will be measured by ultrasonography 10 minutes before the induction of anesthesia.After the measurement, the patients will be monitored with 3-lead electrocardiography, pulse oximetry and noninvasive blood pressure in the operating room. Before induction of general anesthesia, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP), oxygen saturation and heart rate will measured for 3 minutes at 1-minute intervals. Induction of anesthesia with 1-2 mg/kg propofol, muscle relaxation will be achieved with 0.6 mg/kg intravenous rocuronium. During mask ventilation, 1-2% concentration of sevoflurane and 50-50% oxygen-nitrous oxide will be used. After the anesthesia induction, SBP, DBP, MAP, oxygen saturation and heart rate will be measured for 3 minutes at 1-minute intervals.
Hypotension; defined as a 30% reduction in SBP or a 20% reduction in MAP, or an absolute SBP below 90 mm Hg and MAP below 65 mm Hg within 3 minutes of induction of general anesthesia.Intravenous (iv) noradrenaline and/or iv crystalloid will be used in the treatment of hypotension.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients > 65 years old who will undergo elective surgery under general anesthesia will be include in the study. In the preoperative unit, the FTc value in B-mode will be measured under ultrasound guidance (Esaote, MyLab tm Six Ultrasound). After the measurement, in the operating room the patients will be monitored with 3-lead electrocardiography, pulse oximetry, and noninvasive blood pressure (Infinity Kappa monitor, GE Medical Systems, Inc, Telford, PA). Before induction of anesthesia, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) and heart rate will be measured for 3 minutes at 1-minute intervals. Anesthesia induction will be achieved with iv 1-2 mg/kg of propofol and iv 0.6 mg/kg rocuronium will be added for muscle relaxation.Sevoflurane 1-2% and 50-50% oxygen-nitrous oxide will be used during mask ventilation. After anesthesia induction, SBP, DBP, MAP and heart rate will be measured for 3 minutes at 1-minute intervals.
Key inclusion criteria (2 listed)
- >65 years old
- undergoing elective surgery under general anesthesia
Key exclusion criteria (13 listed)
- Mean arterial pressure < 70 mmHg
- Systolic blood pressure > 180 mmHg
- Diastolic blood pressure > 110 mmHg
- < 65 years old
- Carotid artery stenosis > 50%
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 |
|---|---|---|
| ultrasound-guided carotid artery flow time measurementUltrasound-guided corrected carotid artery flow time will be measured before anestesia induction. | Device | – |
Primary outcome
anesthesia induction related hypotension
Time frame: at 1 minute after anesthesia induction, at 2 minutes after anesthesia induction, at 3 minutes anesthesia induction
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MAP) were measured 1 minute before anesthesia induction and after anesthesia induction (at 1 minute intervals for 3 minutes). Hypotension was defined as 30% decrease in SBP or a 20% decrease in MAP or absolute SBP less than 90 mm Hg, and MAP below 65 mm Hg within 3 minutes of induction of general anaesthesia.
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 8 Dec 2023.
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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 Flow Time and Carotid Doppler Ultrasound, run by Cukurova 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 2 inclusion and 13 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 8 Dec 2023. 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?
anesthesia induction related hypotension (time frame: at 1 minute after anesthesia induction, at 2 minutes after anesthesia induction, at 3 minutes anesthesia induction). 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 8 Dec 2023.