- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05076929
Assessment of Ultrasonographic Measurement of Inferior Vena Cava Collapsibility Index in Prediction of Hypotension Associated With Tourniquet Release in Total Knee Replacement Surgeries Under Spinal Anesthesia
September 29, 2022 updated by: Mona Ammar, Ain Shams University
Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery.
Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
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
-
-
-
Cairo, Egypt
- ain shams University
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Total Knee Replacement Surgeries under Spinal Anesthesia
Description
Inclusion Criteria:
- ASA grade I, II, III
- Age 18 -65 yrs
- Spinal Anesthesia
Exclusion Criteria:
- Patient refusal
- Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) .
- Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory disease.
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 |
---|---|
mean arterial blood pressure
Time Frame: 15 minutes after tourniquet release
|
15 minutes after tourniquet release
|
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)
May 28, 2021
Primary Completion (Actual)
February 1, 2022
Study Completion (Actual)
March 1, 2022
Study Registration Dates
First Submitted
September 26, 2021
First Submitted That Met QC Criteria
October 12, 2021
First Posted (Actual)
October 13, 2021
Study Record Updates
Last Update Posted (Actual)
October 3, 2022
Last Update Submitted That Met QC Criteria
September 29, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS 292/ 2021
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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