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NCT Number: NCT07286422

Efficacy of Subclavian Vein/Artery Diameter Index in Predicting the Incidence of the Spinal-Induced Hypotension in Geriatric Patients

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.

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Key information

Conditions

Spinal Induced Hypotension Frailty Old Age; Debility Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

tarek Abdelhay Mostafa

Tanta, El Gharbyia, 31111, Egypt

About this study

Ultrasonography (USG)-guided measurement of inferior vena cava (IVC) diameters and IVC collapsibility index (IVCCI) are reliable indicators of intravascular volume status and of clinical response to volume resuscitation.

The cava/aorta index had previously shown good ability in assessing volume status and predicting post-spinal hypotension.

The subclavian vein (SCV) is advantageous for measurement as it's supported by the clavicle, preventing deformation or compression. It is also not affected by pregnancy, obesity, or abdominal pain, and its anatomical position remains fixed.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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.

Exclusion criteria

  • 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.

Treatment and study plan

Assessment of the SCV & SCA

Diagnostic Test

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

Assessment of the IVC and aorta

Diagnostic Test

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

Primary outcomes

  1. subclavian vein to artery index

    Time frame: pre-anesthesia peroid

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

Study contacts

Contact information is provided by the study sponsor or research team.

sameh Ahmed

CONTACT

[email protected]

tarek AH Mostafa

CONTACT

[email protected]

01003591332

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Efficacy of Subclavian Vein/Artery Diameter Index in Predicting the Incidence of the Spinal-Induced Hypotension in Geriatric Patients: A Prospective, Observational Study.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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