Spinal Induced HypotensionNCT07286422
Efficacy of Subclavian Vein/Artery Diameter Index in Predicting the Incidence of the Spinal-Induced Hypotension in Geriatric Patients
An observational study of Spinal Induced Hypotension and Old Age; Debility, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Induced Hypotension, Old Age; Debility
- What is being tested?
- Assessment of the SCV & SCA and Assessment of the IVC and aorta
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 107 geriatric patients, aged 65 or older, scheduled for elective surgery under spinal anesthesia
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Spinal Induced Hypotension, Old Age; Debility
- Being tested
- Assessment of the SCV & SCA, Assessment of the IVC and aorta
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the SCV & SCADiagnostic 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 aortaDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
subclavian vein to artery index
The index will be calculated as the ratio between the SCV maximum diameter and the SAD diameter.
Measured: pre-anesthesia peroid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Induced HypotensionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286422
- Sponsor's protocol ID
- SCV with hypotension
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07286422
- Acronym / sponsor ID
- SCV with hypotension
- Conditions
- Spinal Induced Hypotension, Old Age; Debility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 107 geriatric patients, aged 65 or older, scheduled for elective surgery under spinal anesthesia
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the SCV & SCAThe 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 | Diagnostic test | – |
| Assessment of the IVC and aortaThe 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 | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Induced Hypotension and Old Age; Debility, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subclavian vein to artery index (time frame: pre-anesthesia peroid). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.