- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07742904
SV and IVC Collapsibility Index to Predict Postinduction Hypotension
September 5, 2026 updated by: Ain Shams University
Stroke Volume Versus Inferior Vena Cava Collapsibility Index to Predict Postinduction Hypotension in Intestinal Obstruction
Postinduction hypotension (PIH) is a frequent complication during general anesthesia.
This study aims to compare the predictive effectiveness and diagnostic accuracy of stroke volume (SV) measured via left ventricular outflow tract velocity time integral (LVOT-VTI) versus the inferior vena cava collapsibility index (IVC-CI) using transthoracic echocardiography.
The assessment will be conducted in adult patients with intestinal obstruction undergoing exploratory abdominal surgery under general anesthesia.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Postinduction hypotension (PIH) is associated with adverse postoperative outcomes.
In this diagnostic accuracy observational study, adult patients aged 40-70 years with intestinal obstruction undergoing exploratory abdominal surgery under general anesthesia will be enrolled at Ain Shams University Hospitals.
Prior to induction of general anesthesia, transthoracic echocardiography (TTE) will be performed to measure the stroke volume (SV) via LVOT-VTI and the inferior vena cava collapsibility index (IVC-CI).
Patients will receive standard rapid sequence induction, and hemodynamic parameters will be monitored post-induction to evaluate the predictive value, sensitivity, and specificity of SV versus IVC-CI for postinduction hypotension.
Secondary outcomes including incidence of PIH, length of hospital stay, PACU recovery time, and postoperative nausea and vomiting will also be recorded.
Study Type
Observational
Enrollment (Estimated)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Noura A Kamal, M.Sc.
- Phone Number: +201119774236
- Email: NouraAbdel-Monem@med.asu.edu.eg
Study Contact Backup
- Name: Islam A Taher, M.D.
- Phone Number: +201005629809
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Adult patients diagnosed with intestinal obstruction scheduled for exploratory abdominal surgery under general anesthesia at Ain-Shams University Hospitals.
Description
Inclusion Criteria:
- Adult patients with intestinal bowel obstruction undergoing exploratory abdominal surgery under general anesthesia.
- Age 40 to 70 years old.
- Body Mass Index (BMI) = 18 to 25 kg/m2.
- American Society of Anesthesiologists (ASA) physical status grade I or II.
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status grade >= III.
- Patients in whom the IVC cannot be visualized or patients with poor echogenicity.
- Patients with hemodynamic instability.
- Patients with vascular, respiratory, or cardiac diseases (e.g., cardiomyopathy, heart valve disease, arrhythmia, or bad exercise tolerance).
- Pregnant patients.
- Difficult airway or multiple intubatio
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic accuracy of Stroke Volume (SV) to predict post-induction hypotension.
Time Frame: Baseline (pre-induction) and immediately post-induction.
|
Area under the receiver operating characteristic curve (AUC) of stroke volume measured via left ventricular outflow tract velocity-time integral (LVOT-VTI) as a predictor of post-induction hypotension.
|
Baseline (pre-induction) and immediately post-induction.
|
|
Diagnostic accuracy of Inferior Vena Cava Collapsibility Index (IVC-CI) to predict post-induction hypotension.
Time Frame: Baseline (pre-induction) and immediately post-induction.
|
Area under the receiver operating characteristic curve (AUC) of inferior vena cava collapsibility index measured via transthoracic echocardiography (TTE) as a predictor of post-induction hypotension.
|
Baseline (pre-induction) and immediately post-induction.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Hospital Stay Length of Hospital Stay
Time Frame: From date of surgery until hospital discharge (up to 9 months).
|
Total duration of hospitalization from the day of surgery until discharge.
|
From date of surgery until hospital discharge (up to 9 months).
|
|
Time to Recovery from Post-Anesthesia Care Unit (PACU) Time to Recovery from Post-Anesthesia Care Unit (PACU)
Time Frame: Intraoperative / immediate postoperative period until PACU discharge (up to 24 hours).
|
Time elapsed from patient admission to the PACU until meeting discharge criteria. Time elapsed from patient admission to the PACU until meeting discharge criteria. |
Intraoperative / immediate postoperative period until PACU discharge (up to 24 hours).
|
|
Incidence of Post-Induction Hypotension
Time Frame: Within 3 minutes following induction of general anesthesia.
|
Assessment of the proportion of patients who develop post-induction hypotension, defined as SBP decrease > 30%, MAP decrease > 20% from baseline, or absolute SBP < 90 mmHg and MAP < 60 mmHg.
|
Within 3 minutes following induction of general anesthesia.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Mohamed H Shokeir, M.D., Ph.D., Ain Shams University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
July 29, 2026
First Submitted That Met QC Criteria
July 29, 2026
First Posted (Actual)
August 3, 2026
Study Record Updates
Last Update Posted (Actual)
September 10, 2026
Last Update Submitted That Met QC Criteria
September 5, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD49/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data will not be shared to protect patient privacy and confidentiality.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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