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
1 other identifier
observational
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 28, 2021
CompletedFirst Submitted
Initial submission to the registry
September 26, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedOctober 3, 2022
September 1, 2022
8 months
September 26, 2021
September 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
mean arterial blood pressure
15 minutes after tourniquet release
Interventions
Ultrasonographic measurement of Inferior Vena Cava Collapsibility Index
Eligibility Criteria
Total Knee Replacement Surgeries under Spinal Anesthesia
You may qualify if:
- ASA grade I, II, III
- Age 18 -65 yrs
- Spinal Anesthesia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 26, 2021
First Posted
October 13, 2021
Study Start
May 28, 2021
Primary Completion
February 1, 2022
Study Completion
March 1, 2022
Last Updated
October 3, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share