SV and IVC Collapsibility Index to Predict Postinduction Hypotension
Stroke Volume Versus Inferior Vena Cava Collapsibility Index to Predict Postinduction Hypotension in Intestinal Obstruction
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Investigators
Investigators
- Study Chair: Mohamed H Shokeir, M.D., Ph.D., Ain Shams University
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- FMASU MD49/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.