- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04658576
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a Predictor for Post-induction Hypotension
July 2, 2023 updated by: Shymaa Fathy, Cairo University
Pre-operative Ultrasonographic Evaluation of Caval Aorta Diameter Index as a New Predictor for Hypotension After Induction of General Anaesthesia: A Prospective Observational Cohort Study.
Comparison between ultrasound measurement of IVCD-AOd index in prediction of post induction hypo tension
Study Overview
Status
Completed
Conditions
Detailed Description
This study aims to evaluate the ability of preoperative ultrasound measurements IVC to aorta diameter index to predict post-induction hypotension in comparison with ultrasound measurements of the IVC collapsibility index.
Study Type
Observational
Enrollment (Actual)
96
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt, 11562
- Faculty of Medicine- Cairo University
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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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
• Patients scheduled for elective orthopedic surgeries under general anaesthesia
Description
Inclusion Criteria:
• Adult patients (>18years)
- ASA I-II
Exclusion Criteria:
• ASA physical status > II
- Dyspnea
- Systolic blood pressure ≥ 180 mmHg
- Systolic blood pressure < 90 mmHg
- Agitation (RASS > 1)
- IVC non visualized
- Epidural catheter in use
- Patients with increased intraabdominal pressure (intrabdominal mass compressing IVC).
- Pregnancy
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 |
|---|---|---|
|
• Comparison of the accuracy Area under receiver operating characteristic curves (AUROC) of IVCD:AoD index and IVCCI in prediction of post-induction hypotension
Time Frame: 15 minutes
|
Measurement of pre-operative IVC-AOrta diameter index and IVC collapsibility index
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shymaa Fathy, MD, Cairo 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 (Actual)
December 1, 2020
Primary Completion (Actual)
October 23, 2022
Study Completion (Actual)
October 23, 2022
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 8, 2020
Study Record Updates
Last Update Posted (Actual)
July 5, 2023
Last Update Submitted That Met QC Criteria
July 2, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD-245-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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