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

NCT ID: NCT07286422

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Induced Hypotension Old Age; Debility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Assessment of the SCV & SCA

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

Intervention Type DIAGNOSTIC_TEST

Assessment of the IVC and aorta

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

6\. Patients with increased intra-abdominal pressure, intra-abdominal mass compressing the IVC.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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tarek abdel hay mostafa

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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tarek Abdelhay Mostafa

Tanta, El Gharbyia, Egypt

Site Status

Countries

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Egypt

Central Contacts

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tarek AH Mostafa

Role: CONTACT

01003591332

sameh Ahmed

Role: CONTACT

Other Identifiers

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SCV with hypotension

Identifier Type: -

Identifier Source: org_study_id