- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06767033
Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.
January 5, 2025 updated by: Ain Shams University
The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Prospective Cohort Study conducted in Ain Shams University Hospitals.
Study Type
Observational
Enrollment (Actual)
40
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
- Ain shams university hospitals
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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
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
Description
Inclusion Criteria:
- Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
- Both Sexes.
- Aged 30 to 60 years.
- Body mass index <35 kg/m2
Exclusion Criteria:
- Patients' refusal of procedure or participation in the study.
- Patients with contraindication to spinal anaesthesia.
- Patients with severe cardiovascular or pulmonary disease.
- Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).
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 |
Time Frame |
|---|---|
|
to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 22, 2024
Primary Completion (Actual)
August 22, 2024
Study Completion (Actual)
September 1, 2024
Study Registration Dates
First Submitted
January 5, 2025
First Submitted That Met QC Criteria
January 5, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 5, 2025
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MS89/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
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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