NCT07286422

Brief Summary

The hypothesis of the study will be that the subclavian vein/subclavian artery diameter (SCVD/SCAD) index will be a good predictor of spinal-induced hypotension in geriatric patients.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 2, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 2, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • subclavian vein to artery index

    The index will be calculated as the ratio between the SCV maximum diameter and the SAD diameter.

    pre-anesthesia peroid

Interventions

The right SCV was measured using a linear array probe, placed in the sagittal plane at the deltopectoral triangle (beneath the proximal part of the middle of the clavicle and the area below the clavicle). In M-mode, measurements of SCV internal anteroposterior diameter, which is maximum during expiration (SCVmax) and minimum during inspiration (SCVmin), were taken in one respiratory cycle. Ultrasound scan of the patient's supraclavicular area showing the subclavian artery. The index was calculated as the ratio between the SCV maximum diameter and the SAD diameter

The IVC measurement will be obtained in the M-mode scan using a curvilinear (3.5 to 5 MHz) ultrasound transducer. The transducer was placed longitudinally in the subxiphoid region. The IVC maximum and minimum anterior-posterior diameters were obtained just distal to the IVC-hepatic vein junction. In M-mode, measurements of IVC internal anteroposterior diameter, which is maximum during expiration (IVCmax) and minimum during inspiration. IVCmin), were taken in one respiratory cycle. The abdominal aorta was identified to the left of the IVC, 10 mm above the coeliac trunk. The maximum internal anterior-posterior diameter of the aorta was obtained during systole. The caval /aorta diameter index was calculated as the ratio between the IVC maximum diameter and the aortic diameter. The index had a sensitivity of 96%, a specificity of 88%, and an accuracy of 95% to predict PSAH at a cut-off point of less than 1.2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

107 geriatric patients, aged 65 or older, scheduled for elective surgery under spinal anesthesia

You may qualify if:

  • \. Patients aged 65 or older. 2. Lower body surgeries to be done with spinal anesthesia. 3. BMI less than 30 kg/m2. 4. Patients with ASA I-III.

You may not qualify if:

  • \- 1. Patient refusal. 2. Patients with a history of peripheral arterial disease or atherosclerosis 3. Patients with a body mass index of greater than 30 kg/m2 4. Major bloody surgeries (class C surgeries) 5. Patients with a history of cardiovascular disorders, including arrhythmias, heart failure, tricuspid or mitral regurgitation, dilated right atrium or ventricle, AF, ejection fraction \< 45%, uncontrolled hypertension, systolic blood pressure \<90 mmHg, dyspnea, agitation.
  • \. Patients with increased intra-abdominal pressure, intra-abdominal mass compressing the IVC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

tarek Abdelhay Mostafa

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 16, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations