Femoral Vein DiameterNCT07339475
Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia
An observational study of Femoral Vein Diameter and Intraoperative Hypotension, run by Cairo University at 1 site in Egypt.
Trial summary
The study aims to assess whether the transverse diameter of the right common femoral vein (RCFV) in the inguinal region could reflect the degree of post-spinal hypotension during elective orthopedic surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femoral Vein Diameter, Intraoperative Hypotension, Orthopedic Surgery
- What is being tested?
- Measurement of Femoral Vein Diameter
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The prospective observational study will be conducted in orthopedic theatre in Cairo University Hospitals.
Who may be able to join
- Age > 60 years.
- American Society of Anesthesiologists (ASA) physical state I-II.
- Body mass index (BMI) ≤35 kg/m². Patients above this value will be excluded because obesity may cause technical difficulty and poor image quality in femoral vein ultrasound assessment.
- Elective lower-limb orthopedic surgery under spinal anesthesia.
Who cannot join
- Patients refusing to participate.
- History of psychiatric illness or seizures.
- Absolute contraindications to spinal anesthesia: infection at the puncture site, severe coagulopathy/anticoagulation [defined as platelet count <75,000/µL, International Normalized Ratio (INR) >1.5, Activated Partial Thromboplastin Time (aPTT) >1.5 times control, or the use of anticoagulants such as warfarin, heparin, low molecular weight heparin, or direct oral anticoagulants within the recommended safety interval for neuraxial anesthesia], severe hypovolemia, increased intracranial pressure, or known allergy to local anesthetics.
- Severe cardiac disease, including left ventricular ejection fraction <30%, Severe valvular heart disease (e.g., critical aortic stenosis), clinically significant arrhythmias (atrial fibrillation with uncontrolled ventricular rate >120 bpm, frequent ventricular ectopy or sustained ventricular tachyarrhythmia) and congestive heart failure such as New York Heart Association (NYHA) class III-IV.
- Severe uncontrolled hypertension, defined as persistent mean arterial pressure (MAP) ≥120 mmHg or systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg despite medical therapy.
- Severe respiratory diseases (Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage III-IV chronic obstructive pulmonary disease, or forced vital capacity (FVC) <50% predicted).
- Baseline bradycardia (<50) or mean arterial blood pressure less than 60mmHg.
- Emergency surgeries.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Hebatullah S Abdelhamid, MD, 00201044512277, drhebasalah593@gmail.com
About this study
Official title: Evaluation of Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia: A Prospective Observational Study
The study aims to assess whether the transverse diameter of the right common femoral vein (RCFV) in the inguinal region could reflect the degree of post-spinal hypotension during elective orthopedic surgery.
Read the detailed description
Spinal anesthesia is commonly used in orthopedic procedures but often results in hypotension, particularly in elderly patients due to reduced cardiovascular reserve and impaired autonomic function.
Ultrasound measurement of the right common femoral vein (RCFV) diameter has recently been proposed as a simple, non-invasive marker of intravascular volume status and a potential predictor of spinal anesthesia induced hypotension. To date, most evidence comes from obstetric populations undergoing cesarean delivery, limiting its applicability in other high-risk groups.
- Being tested
- Measurement of Femoral Vein Diameter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Femoral Vein DiameterOther
The transverse diameter of the right common femoral vein (RCFV) will be recorded 1 cm proximal to the junction with the great saphenous vein, at end-expiration.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing elective lower-limb orthopedic surgery under spinal anesthesia Receives: Other: Measurement of Femoral Vein Diameter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive ability of the transverse diameter of the right common femoral vein (RCFV)
The predictive ability of the transverse diameter of the right common femoral vein (RCFV), measured by ultrasound before spinal anesthesia, for the development of post-spinal hypotension in geriatric patients undergoing orthopedic surgery.
Measured: At end-expiration (Up to 15 minutes)
Secondary outcomes (3)
Severity of post spinal hypotension
Severity of post spinal hypotension [defined as a decrease in the mean arterial pressure (MAP) >20% from baseline]. Severity of hypotension, classified as:
- Mild: 20-30% decrease in MAP from baseline.
- Moderate: 30-40% decrease in MAP from baseline.
- Severe: >40% decrease in MAP from baseline or absolute MAP <60 mmHg.
Measured: 24 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as hypotension and/or bradycardia will be recorded.
Measured: 24 hours postoperatively
Requirement of rescue medications
Requirement of rescue medications will be recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Dec 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Vein DiameterStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebatallah Salah Abdelhamid, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339475
- Sponsor's protocol ID
- MS-640-2025
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Femoral Vein Diameter to Predict Intraoperative Hypotension in Geriatric Patients Undergoing Orthopedic Surgery Under Spinal Anesthesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07339475
- Acronym / sponsor ID
- MS-640-2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 14 Jan 2026 (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 study aims to assess whether the transverse diameter of the right common femoral vein (RCFV) in the inguinal region could reflect the degree of post-spinal hypotension during elective orthopedic surgery.
Detailed description
Spinal anesthesia is commonly used in orthopedic procedures but often results in hypotension, particularly in elderly patients due to reduced cardiovascular reserve and impaired autonomic function.
Ultrasound measurement of the right common femoral vein (RCFV) diameter has recently been proposed as a simple, non-invasive marker of intravascular volume status and a potential predictor of spinal anesthesia induced hypotension. To date, most evidence comes from obstetric populations undergoing cesarean delivery, limiting its applicability in other high-risk groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Measurement of Femoral Vein DiameterPatients undergoing elective lower-limb orthopedic surgery under spinal anesthesia |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The prospective observational study will be conducted in orthopedic theatre in Cairo University Hospitals.
Key inclusion criteria (4 listed)
- Age > 60 years.
- American Society of Anesthesiologists (ASA) physical state I-II.
- Body mass index (BMI) ≤35 kg/m². Patients above this value will be excluded because obesity may cause technical difficulty and poor image quality in femoral vein ultrasound assessment.
- Elective lower-limb orthopedic surgery under spinal anesthesia.
Key exclusion criteria (8 listed)
- Patients refusing to participate.
- History of psychiatric illness or seizures.
- Absolute contraindications to spinal anesthesia: infection at the puncture site, severe coagulopathy/anticoagulation [defined as platelet count <75,000/µL, International Normalized Ratio (INR) >1.5, Activated Partial Thromboplastin Time (aPTT) >1.5 times control, or the use of anticoagulants such as warfarin, heparin, low molecular weight heparin, or direct oral anticoagulants within the recommended safety interval for neuraxial anesthesia], severe hypovolemia, increased intracranial pressure, or known allergy to local anesthetics.
- Severe cardiac disease, including left ventricular ejection fraction <30%, Severe valvular heart disease (e.g., critical aortic stenosis), clinically significant arrhythmias (atrial fibrillation with uncontrolled ventricular rate >120 bpm, frequent ventricular ectopy or sustained ventricular tachyarrhythmia) and congestive heart failure such as New York Heart Association (NYHA) class III-IV.
- Severe uncontrolled hypertension, defined as persistent mean arterial pressure (MAP) ≥120 mmHg or systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg despite medical therapy.
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 |
|---|---|---|
| Measurement of Femoral Vein DiameterThe transverse diameter of the right common femoral vein (RCFV) will be recorded 1 cm proximal to the junction with the great saphenous vein, at end-expiration. | Other | Study group |
Primary outcome
Predictive ability of the transverse diameter of the right common femoral vein (RCFV)
Time frame: At end-expiration (Up to 15 minutes)
The predictive ability of the transverse diameter of the right common femoral vein (RCFV), measured by ultrasound before spinal anesthesia, for the development of post-spinal hypotension in geriatric patients undergoing orthopedic surgery.
3 secondary outcomes
Severity of post spinal hypotension
Time frame: 24 hours postoperatively
Incidence of adverse events
Time frame: 24 hours postoperatively
Requirement of rescue medications
Time frame: 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Femoral Vein Diameter and Intraoperative Hypotension, run by Cairo 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 14 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hebatullah S Abdelhamid, MD (00201044512277, drhebasalah593@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive ability of the transverse diameter of the right common femoral vein (RCFV) (time frame: At end-expiration (Up to 15 minutes)). 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 14 Jan 2026.