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Not yet recruiting NCT07286422

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

Observational Spinal Induced Hypotension Old Age; Debility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of the SCV & SCA, Assessment of the IVC and aorta.
Who it may be relevant to
Registry conditions: Spinal Induced Hypotension, Old Age; Debility. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Diagnostic test 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 calcul
  • 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 abdomina

Primary outcome measures

  • subclavian vein to artery index [Time frame: pre-anesthesia peroid]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • tarek Abdelhay Mostafa — Tanta

Identifiers

NCT: NCT07286422 · SCV with hypotension

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗