GeriatricsNCT06814054
Carotid Artery Corrected Flow Time and Inferior Vena Cava Collapsibility Index for Prediction of Hypotension After Induction of General Anesthesia in Geriatric Patients Undergoing Elective Surgery
An observational study of Geriatrics and Hypotension on Induction, run by Tanta University at 1 site in Egypt.
Trial summary
In this observational study, we will assess cFT by Carotid ultrasound and IVC collapsibility index for prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatrics, Hypotension on Induction, General Anesthetic Drug Adverse Reaction
- What is being tested?
- Carotid Artery Corrected Flow Time measurement and Inferior vena cava collapsibility index
- Type of treatment
- Injection or infusion
- How many people
- 189 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Study population: geriatric patients (65 years and above) (10) of either sex and ASA PS I to Ⅱ receiving general anesthesia for elective surgery, who fasted for at least 6 to 8 hours were recruited in this study
Who may be able to join
- American Society of Anaesthesiologists Physical Status I to Ⅱ
- receiving general anesthesia for elective surgery
- fasted for at least 6 to 8 hours were recruited in this study
Who cannot join
- • patients who refused to participate in the study
- American Society of Anaesthesiologists Physical Status Ⅲ or Ⅳ
- Patients with a history of peripheral arterial diseases or atherosclerosis
- Patients with body mass index of greater than 30 kg/m2
- Patients with arrhythmia or cardiomyopathy
- Chronic obstructive pulmonary disease (COPD)
- baseline systolic arterial pressure (SAP) ≥ 180 mmHg or < 90mmHg
- Any episode of desaturation or difficult intubation during general anasethia induction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
sameh Ahmed contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Tanta university
Tanta, El Gharbyia, 31111
tarek Mostafa, 020403332033, dr.tarek311@yahoo.com
About this study
In this observational study, we will assess cFT by Carotid ultrasound and IVC collapsibility index for prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.
Read the detailed description
Following the onset of general anesthesia, hypotension is frequently observed, and intraoperative hypotension is linked to end organ damage following surgery, including cardiac ischemia and severe renal injury. postoperative end-organ damage depends on the duration and magnitude.
The incidence of hypotension after induction of general anesthesia varies and is influenced by the induction agent, patient characteristics, and the definition of hypotension.
Hypotension was defined by a 30% reduction in the SBP or 20% reduction in the MAP from baseline or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within 3 minutes after induction of general anesthesia.
Elderly people are more likely to experience hemodynamic fluctuation and hypotension due to the high prevalence of left ventricular diastolic failure, lower vascular reactivity and higher sensitivity to anesthetics. More significantly, older patients can't tolerate hypotension for a long time.
A variety of hemodynamic monitoring techniques have been used to predict post- anesthetic hypotension. Non-invasive cardiometry, ultrasound evaluation of fluid status, and pulse oximetry variables, such as the perfusion index and pulse variability index, were utilized.
Zhang and Critchley demonstrated that preoperative hypovolemia predicted postinduction hypotension as determined by the inferior vena cava (IVC) diameter and IVC collapsibility index.
In many clinical situations, volume-responsive patients have been identified using Doppler-derived metrics such as the peak blood flow peak velocity variation (ðVpeak) and the common carotid artery corrected flow time (cFT).
The carotid artery Doppler measures provide several benefits, including being noninvasive and being technically simple to obtain due to the carotid artery's superficial nature. Since the common carotid artery cFT is unaffected by respiratory attempts, it can also be used to assess a patient's volume responsiveness when they are breathing on their own.
- Conditions
- Geriatrics, Hypotension on Induction, General Anesthetic Drug Adverse Reaction, Elective Surgery
- Being tested
- Carotid Artery Corrected Flow Time measurement, Inferior vena cava collapsibility index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Artery Corrected Flow Time measurementDiagnostic test
- The cFT is defined as the time between the onset of systolic flow until closure of the aortic valve corrected for the HR and has been found to correlate with the intravascular volume.
- carotid ultrasound imaging will be performed 10 minutes before induction of general anesthesia in the preoperative holding area.
- Ultrasound measurements will be performed under a vascular setting with a 6.0 to 13.0MHz linear array transducer
- The right common carotid artery cFT will be measured in supine position with their heads tilted 30° to the left
- After that, a pulse wave Doppler will be chosen, and the sampling frame will be positioned at an angle of less than 60° in the region of the carotid artery with the best color flow to acquire the blood flow spectrum.
Inferior vena cava collapsibility indexDiagnostic test
- The IVC will be examined while the patient has been spontaneously, quietly breathing and lying in the supine position for at least 5 min before assessment.
- A two-dimensional image of the IVC as it entered the right atrium will be obtained through the paramedian long-axis view via a subcostal approach using a curvilinear phased array probe (2-5 MHz)
- Then, using M-mode imaging produced at a medium sweep speed, changes in IVC diameter with breathing will be evaluated 2 to 3 cm distal to the right atrium.
- During the same respiratory cycle, measurements will be made of the IVC's greatest expiratory diameter (dIVC expiration) and lowest inspiratory diameter (dIVC inspiration). The formula IVCCI = (dIVC expiration - dIVC inspiration) × 100/dIVC expiration will be used to determine IVCCI as a percentage. (12)
- IVCCI will be assessed by the same trained anesthesiologist who was blinded to postin duction hemodynamic measurements.
| Study group | Role | What they receive |
|---|---|---|
| GA induced hypotension in geriatrics | Postinduction hypotension will be defined as either
* A 30% drop in SBP or 20% drop in MAP from baseline, or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within three minutes of general anaesthesia induction, every minute until 15 min after endotracheal intubation and before the start of any surgical manipulations.
* Since endotracheal intubation and direct laryngoscopy can generate sympathetic activation, which will change blood pressure, we decided to start haemodynamic monitoring three minutes post endotracheal intubation.
* If the MAP was less than 65 mmHg, a 250 ml crystalloid bolus will be administered and repeated as necessary.
* If hypotension persist after IV fluid bolus, ephedrine will be given by three milligrams.
At the end of surgery. Receives: Diagnostic Test: Carotid Artery Corrected Flow Time measurement; Diagnostic Test: Inferior vena cava collapsibility index |
What is being measured
The primary outcome is the main question the study is designed to answer.
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.
Measured: immediate preoperative peroid before the 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 Feb 2025
- Study start1 Mar 2025
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
- Investigators
- tarek Mostafa, Principal investigator, tanta university, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814054
- Sponsor's protocol ID
- Hypotension in geriatrics
- Status last verified
- Jun 2025
- First submitted
- 3 Feb 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Artery Corrected Flow Time and Inferior Vena Cava Collapsibility Index for Prediction of Hypotension After Induction of General Anesthesia in Geriatric Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT06814054
- Acronym / sponsor ID
- Hypotension in geriatrics
- Conditions
- Geriatrics, Hypotension on Induction, General Anesthetic Drug Adverse Reaction, Elective Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 7 Feb 2025 (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.
In this observational study, we will assess cFT by Carotid ultrasound and IVC collapsibility index for prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.
Detailed description
Following the onset of general anesthesia, hypotension is frequently observed, and intraoperative hypotension is linked to end organ damage following surgery, including cardiac ischemia and severe renal injury. postoperative end-organ damage depends on the duration and magnitude.
The incidence of hypotension after induction of general anesthesia varies and is influenced by the induction agent, patient characteristics, and the definition of hypotension.
Hypotension was defined by a 30% reduction in the SBP or 20% reduction in the MAP from baseline or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within 3 minutes after induction of general anesthesia.
Elderly people are more likely to experience hemodynamic fluctuation and hypotension due to the high prevalence of left ventricular diastolic failure, lower vascular reactivity and higher sensitivity to anesthetics. More significantly, older patients can't tolerate hypotension for a long time.
A variety of hemodynamic monitoring techniques have been used to predict post- anesthetic hypotension. Non-invasive cardiometry, ultrasound evaluation of fluid status, and pulse oximetry variables, such as the perfusion index and pulse variability index, were utilized.
Zhang and Critchley demonstrated that preoperative hypovolemia predicted postinduction hypotension as determined by the inferior vena cava (IVC) diameter and IVC collapsibility index.
In many clinical situations, volume-responsive patients have been identified using Doppler-derived metrics such as the peak blood flow peak velocity variation (ðVpeak) and the common carotid artery corrected flow time (cFT).
The carotid artery Doppler measures provide several benefits, including being noninvasive and being technically simple to obtain due to the carotid artery's superficial nature. Since the common carotid artery cFT is unaffected by respiratory attempts, it can also be used to assess a patient's volume responsiveness when they are breathing on their own.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GA induced hypotension in geriatrics | – | Diagnostic Test: Carotid Artery Corrected Flow Time measurement, Diagnostic Test: Inferior vena cava collapsibility indexPostinduction hypotension will be defined as either * A 30% drop in SBP or 20% drop in MAP from baseline, or an absolute SBP of less than 90 mm Hg and MAP of less than 65 mm Hg within three minutes of general anaesthesia induction, every minute until 15 min after endotracheal intubation and before the start of any surgical manipulations. * Since endotracheal intubation and direct laryngoscopy can generate sympathetic activation, which will change blood pressure, we decided to start haemodynamic monitoring three minutes post endotracheal intubation. * If the MAP was less than 65 mmHg, a 250 ml crystalloid bolus will be administered and repeated as necessary. * If hypotension persist after IV fluid bolus, ephedrine will be given by three milligrams. At the end of surgery. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- geriatric patients (65 years and above) (10) of either sex and ASA PS I to Ⅱ receiving general anesthesia for elective surgery, who fasted for at least 6 to 8 hours were recruited in this study
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists Physical Status I to Ⅱ
- receiving general anesthesia for elective surgery
- fasted for at least 6 to 8 hours were recruited in this study
Key exclusion criteria (8 listed)
- • patients who refused to participate in the study
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 |
|---|---|---|
| Carotid Artery Corrected Flow Time measurement* The cFT is defined as the time between the onset of systolic flow until closure of the aortic valve corrected for the HR and has been found to correlate with the intravascular volume. * carotid ultrasound imaging will be performed 10 minutes before induction of general anesthesia in the preoperative holding area. * Ultrasound measurements will be performed under a vascular setting with a 6.0 to 13.0MHz linear array transducer * The right common carotid artery cFT will be measured in supine position with their heads tilted 30° to the left * After that, a pulse wave Doppler will be chosen, and the sampling frame will be positioned at an angle of less than 60° in the region of the carotid artery with the best color flow to acquire the blood flow spectrum. | Diagnostic test | GA induced hypotension in geriatrics |
| Inferior vena cava collapsibility index* The IVC will be examined while the patient has been spontaneously, quietly breathing and lying in the supine position for at least 5 min before assessment. * A two-dimensional image of the IVC as it entered the right atrium will be obtained through the paramedian long-axis view via a subcostal approach using a curvilinear phased array probe (2-5 MHz) * Then, using M-mode imaging produced at a medium sweep speed, changes in IVC diameter with breathing will be evaluated 2 to 3 cm distal to the right atrium. * During the same respiratory cycle, measurements will be made of the IVC's greatest expiratory diameter (dIVC expiration) and lowest inspiratory diameter (dIVC inspiration). The formula IVCCI = (dIVC expiration - dIVC inspiration) × 100/dIVC expiration will be used to determine IVCCI as a percentage. (12) * IVCCI will be assessed by the same trained anesthesiologist who was blinded to postin duction hemodynamic measurements. | Diagnostic test | GA induced hypotension in geriatrics |
Primary outcome
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients
Time frame: immediate preoperative peroid before the induction of general anesthesia
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients undergoing elective surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- 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.
sameh Ahmed contact
tarek Mostafa principal investigator
tanta university, faculty of medicine
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 Geriatrics and Hypotension on Induction, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Jul 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact tarek AH Mostafa (01003591332, dr.tarek311@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the diagnostic efficacy of cFT by Carotid ultrasound and IVC collapsibility index in prediction of hypotension after induction of general anesthesia in geriatric patients (time frame: immediate preoperative peroid before the 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 1 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.