- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286422
Efficacy of Subclavian Vein/Artery Diameter Index in Predicting the Incidence of the Spinal-Induced Hypotension in Geriatric Patients
Efficacy of Subclavian Vein/Artery Diameter Index in Predicting the Incidence of the Spinal-Induced Hypotension in Geriatric Patients: A Prospective, Observational Study.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: sameh Ahmed
- Email: samehabdelkhalik1982@gmail.com
Study Contact Backup
- Name: tarek AH Mostafa
- Phone Number: 01003591332
- Email: dr.tarek311@yahoo.com
Study Locations
-
-
El Gharbyia
-
Tanta, El Gharbyia, Egypt, 31111
- tarek Abdelhay Mostafa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
pre-anesthesia peroid
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCV with hypotension
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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