Inferior Vena CavaNCT07399093
Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index After Induction of General Anesthesia
An observational study of Inferior Vena Cava and Collapsibility Index, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Inferior Vena Cava, Collapsibility Index, Caval Aorta Index
- What is being tested?
- Inferior vena cava collapsibility index and Caval Aorta Index
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2024to 1 Mar 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This prospective cohort study will be conducted on 40 patients undergoing craniotomy surgeries at Ain Shams University Hospitals.
Who may be able to join
- Age from 18 to 40 years.
- Both sexes.
- Body Mass Index< 40 kg/m².
- American Society of Anesthesiologists (ASA) physical status I, II.
- Fasted according to the ASA guidelines: 2 hours for clear fluids, 6 hours after light meal, 8 hours after a full meal with high calorie or fat content.
- Scheduled for elective craniotomy surgeries before induction of general anesthesia.
Who cannot join
- Current or recent pregnancy (within 3 months).
- Pre-existing cardiac disease or hypertension.
- On medications affecting blood pressure [Beta-blockers (BBs) and calcium channel blockers (CCBs)] .
- Refusing to undergo the study.
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
Ain Shams University Hospitals
Cairo, 11591
Verina F Bekheet, MSc, 00201098858385, verina.fares@med.asu.edu.eg
Sherif W Sarguios, MD
About this study
Official title: Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anesthesia in Patients Undergoing Craniotomy Surgeries
This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.
Read the detailed description
Post- anesthesia hypotension is of common occurrence, and it hampers tissue perfusion. The magnitude of hypotension is determined by the preoperative volume status, which varies depending on American Society of Anesthesiologists (ASA) physical status, preoperative comorbidities, preoperative medications, and fasting.
General anesthesia causes significant alterations in hemodynamics, as both inhalational and intravenous anesthetics cause bradycardia, decrease in systemic vascular resistance and vasodilatation, and decrease in myocardial contractility, cardiac output and stroke volume, with the absence of surgical stimulus, making induction of anesthesia is the most crucial period at which hypotension occurs.
Due to different definitions of hypotension and diverse patient populations, the effect of volume preload on prevention of hypotension is still controversial. Many recommendations to identified sonographic determination of inferior vena cava (IVC) collapsibility index (IVCCI) as non-invasive, and easy technique for evaluating volume status. Recent guidelines from the American Society of Echocardiography support the general use of IVCCI in assessing volume status.
- Conditions
- Inferior Vena Cava, Collapsibility Index, Caval Aorta Index, Induction, General Anesthesia, Craniotomy
- Being tested
- Inferior vena cava collapsibility index, Caval Aorta Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inferior vena cava collapsibility indexOther
Inferior vena cava (IVC) collapsibility index (IVCCI) will be measured.
The IVCCI is calculated using the following formula:
IVCCI = (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter * 100
Caval Aorta IndexOther
The Inferior vena cava (IVC): Ao index will be derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole.
- The caval aorta index (IVC/Ao) is calculated using the following formula: IVC/Ao index = IVC diameter / aortic diameter.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients scheduled for elective craniotomy surgeries before induction of general anesthesia. Receives: Other: Inferior vena cava collapsibility index; Other: Caval Aorta Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO)
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.
Measured: 15 minutes post-induction of general anesthesia.
Secondary outcomes (3)
Specificity of ultrasound guided Aorto-Caval index (IVC-AO)
Specificity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.
Measured: 15 minutes post-induction of general anesthesia.
Sensitivity of inferior vena cava (IVC) collapsibility index
Sensitivity of inferior vena cava (IVC) collapsibility index to predict hypotension will be recorded.
Measured: 15 minutes post-induction of general anesthesia.
Specificity of inferior vena cava (IVC) collapsibility index
Specificity of inferior vena cava (IVC) collapsibility index to predict hypotension will be recorded.
Measured: 15 minutes post-induction of general anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start14 Jan 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inferior Vena CavaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verina Fares Zaref Bekheet, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399093
- Sponsor's protocol ID
- FMASU MD08/2024
- Status last verified
- Feb 2026
- First submitted
- 24 Jul 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Evaluation of IVC Collapsibility Index and Caval Aorta Index for Prediction of Hypotension After Induction of General Anesthesia in Patients Undergoing Craniotomy Surgeries
- ClinicalTrials.gov ID
- NCT07399093
- Acronym / sponsor ID
- FMASU MD08/2024
- Conditions
- Inferior Vena Cava, Collapsibility Index, Caval Aorta Index, Induction, General Anesthesia, Craniotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Jan 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 10 Feb 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.
This study aims to assess the accuracy, repeatability, and reproducibility of preoperative evaluation of Inferior Vena Cava (IVC) collapsibility index and caval aorta index for prediction of hypotension after induction of general anesthesia.
Detailed description
Post- anesthesia hypotension is of common occurrence, and it hampers tissue perfusion. The magnitude of hypotension is determined by the preoperative volume status, which varies depending on American Society of Anesthesiologists (ASA) physical status, preoperative comorbidities, preoperative medications, and fasting.
General anesthesia causes significant alterations in hemodynamics, as both inhalational and intravenous anesthetics cause bradycardia, decrease in systemic vascular resistance and vasodilatation, and decrease in myocardial contractility, cardiac output and stroke volume, with the absence of surgical stimulus, making induction of anesthesia is the most crucial period at which hypotension occurs.
Due to different definitions of hypotension and diverse patient populations, the effect of volume preload on prevention of hypotension is still controversial. Many recommendations to identified sonographic determination of inferior vena cava (IVC) collapsibility index (IVCCI) as non-invasive, and easy technique for evaluating volume status. Recent guidelines from the American Society of Echocardiography support the general use of IVCCI in assessing volume status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Inferior vena cava collapsibility index, Other: Caval Aorta IndexPatients scheduled for elective craniotomy surgeries before induction of general anesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This prospective cohort study will be conducted on 40 patients undergoing craniotomy surgeries at Ain Shams University Hospitals.
Key inclusion criteria (6 listed)
- Age from 18 to 40 years.
- Both sexes.
- Body Mass Index< 40 kg/m².
- American Society of Anesthesiologists (ASA) physical status I, II.
- Fasted according to the ASA guidelines: 2 hours for clear fluids, 6 hours after light meal, 8 hours after a full meal with high calorie or fat content.
Key exclusion criteria (4 listed)
- Current or recent pregnancy (within 3 months).
- Pre-existing cardiac disease or hypertension.
- On medications affecting blood pressure [Beta-blockers (BBs) and calcium channel blockers (CCBs)] .
- Refusing to undergo the study.
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 |
|---|---|---|
| Inferior vena cava collapsibility indexInferior vena cava (IVC) collapsibility index (IVCCI) will be measured. The IVCCI is calculated using the following formula: IVCCI = (maximum IVC diameter - minimum IVC diameter) / maximum IVC diameter * 100 | Other | Study group |
| Caval Aorta IndexThe Inferior vena cava (IVC): Ao index will be derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole. - The caval aorta index (IVC/Ao) is calculated using the following formula: IVC/Ao index = IVC diameter / aortic diameter. | Other | Study group |
Primary outcome
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO)
Time frame: 15 minutes post-induction of general anesthesia.
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO) to predict hypotension will be recorded.
3 secondary outcomes
Specificity of ultrasound guided Aorto-Caval index (IVC-AO)
Time frame: 15 minutes post-induction of general anesthesia.
Sensitivity of inferior vena cava (IVC) collapsibility index
Time frame: 15 minutes post-induction of general anesthesia.
Specificity of inferior vena cava (IVC) collapsibility index
Time frame: 15 minutes post-induction of general anesthesia.
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 10 Feb 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 Inferior Vena Cava and Collapsibility Index, run by Ain Shams 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 6 inclusion and 4 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 10 Feb 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 Verina F Zaref, MSc (00201098858385, verina.fares@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ultrasound guided Aorto-Caval index (IVC-AO) (time frame: 15 minutes post-induction of general anesthesia.). 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 10 Feb 2026.