Carotid Ultrasound for Post-Spinal Anesthesia Hypotension in Elderly Hip Surgery

NCT07876063 | Not Yet Recruiting DMC

• 1 other identifier: 36266MD5/8/26
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the predictability of preoperative carotid artery-corrected flow time (CFTc) for hypotension after spinal anesthesia in patients undergoing geriatric hip replacement surgery. Primary outcomes:

• The predictive performance of preoperative CFTc for post-spinal hypotension . Secondary outcomes:
• Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of CFTc in prediction of hypotension.
• Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of IVC collapsibility.
• Cut-off value, sensitivity, specificity, positive predictive value and negative predictive value of echocardiography (ECHO) (LVOT-VTI).
• Comparison of predictive accuracy of CFTc, IVC, and ECHO for post-spinal hypotension.
• Monitoring of systolic blood pressure (SBP), mean arterial pressure (MAP), and heart rate (HR) (first 10 min every 2 minutes, then at 15 min and at 20 min).

Conditions

Hypotension After Spinal Anesthesia

Keywords

Post-spinal hypotension; Carotid Doppler ultrasound; Corrected carotid flow time (CFTc); Total hip arthroplasty; Hemodynamic monitoring

Outcome Measures

Primary Outcomes (1)

• Predictive Performance of Preoperative Corrected Carotid Flow Time (CFTc) for Post-Spinal Hypotension

  Carotid flow time is measured preoperatively via pulsed-wave Doppler ultrasound of the common carotid artery. A high-frequency linear ultrasound probe is positioned over the common carotid artery proximal to its bifurcation. The flow time is measured from the systolic upstroke to the dicrotic notch and is then corrected for heart rate using Wodey's formula across three averaged cycles.

  Preoperative (Baseline, before spinal anesthesia).

Secondary Outcomes (6)

• Optimal Cut-Off Value of Corrected Carotid Flow Time (CFTc)

  Within the first 20 minutes following spinal anesthesia.

• Optimal Cut-Off Value of Inferior Vena Cava Collapsibility Index (IVCCI)

  Within the first 20 minutes following spinal anesthesia.

• Optimal Cut-Off Value of Left Ventricular Outflow Tract Velocity Time Integral (LVOT-VTI)

  Within the first 20 minutes following spinal anesthesia.

• Comparison of Area Under the Curve (AUC) for CFTc, IVCCI, and LVOT-VTI

  Within the first 20 minutes following spinal anesthesia.

• Hemodynamic Monitoring: Systolic Blood Pressure (SBP) and Mean Arterial Pressure (MAP)

  Measured at 2, 4, 6, 8, and 10 minutes, then at 15 minutes and 20 minutes following spinal anesthesia administration.

Interventions

Ultrasound DEVICE

Preoperative point-of-care ultrasonography is performed using a diagnostic ultrasound system (SONY, General Electric (GE) Medical Systems) to evaluate baseline intravascular volume and hemodynamic status before spinal anesthesia. A high-frequency linear ultrasound probe is positioned over the common carotid artery proximal to its bifurcation to record pulsed-wave Doppler waveforms, measuring flow time from systolic upstroke to the dicrotic notch and calculating the corrected carotid flow time (CFTc) using Wodey's formula across three averaged cycles. The ultrasound device is additionally used with a 2-4 megahertz (MHz) transducer to measure the inferior vena cava collapsibility index (IVCCI) via subcostal M-mode imaging during an inspiratory sniff, as well as the left ventricular outflow tract velocity time integral (LVOT-VTI) via apical five-chamber echocardiography, to determine their accuracy in predicting post-spinal anesthesia hypotension.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Geriatric patients aged 65 years and older of either sex scheduled for elective hip replacement surgery under spinal anesthesia at the Anesthesia Department of Tanta University Hospital.

You may qualify if:

• Patients aged 65 years or older
• Both sexes
• Scheduled for elective hip replacement surgery under spinal anesthesia
• American Society of Anesthesiologists (ASA) physical status classification I, II, or III

You may not qualify if:

• Patient refusal to participate
• Severe carotid artery stenosis (\> 50%)
• Cardiac arrhythmias
• Severe valvular heart disease
• Uncontrolled hypertension
• Hepatic or renal impairment
• Infection at the intended site of spinal injection
• Any contraindications to spinal anesthesia

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine, Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Abdelraheem M Dowidar, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha M El-Gazzar, M.Sc.

CONTACT

+201010468790; mahamahmoud936@gmail.com

Alaa M Abo Hagar, M.D.

CONTACT

+201099220281

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecture of anesthesia and icu department

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: October 15, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)