(∆PI) to Predict Post-spinal Anesthesia Hypotension
The Change in Femoral Artery Pulsatility Index as a Novel Predictor to Post-spinal Hypotension in Adult Patient Undergoing Infraumbilical Surgeries, a Prospective Observational Study
1 other identifier
observational
54
1 country
1
Brief Summary
we aimed to evaluate the change in femoral artery pulsatility index as a predictor to post-spinal anesthesia hypotension
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 Jul 2024
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
First Submitted
Initial submission to the registry
June 29, 2024
CompletedFirst Posted
Study publicly available on registry
July 8, 2024
CompletedStudy Start
First participant enrolled
July 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2024
CompletedNovember 5, 2024
November 1, 2024
3 months
June 29, 2024
November 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
change in pulsatility index to predict post spinal anesthesia induced hypotension
to measure PI before and after spinal anesthesia
baseline and immediately after spinal anesthesia
Secondary Outcomes (2)
change in resistive index to predict post spinal anesthesia induced hypotension
baseline and immediately after spinal anesthesia
change in waveform morphology to predict post spinal hypotension
before and immediately after spinal anesthesia
Interventions
femoral artery pulse wave doppler to measure both pulsatility and resistive indices
Eligibility Criteria
adult patient undergoing spinal anesthesia for infra-umbilical surgeries
You may qualify if:
- adult patient undergoing infra-umbilical surgeries.
You may not qualify if:
- coagulopathy peripheral vascular disease contraindication to spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (3)
Hartmann B, Junger A, Klasen J, Benson M, Jost A, Banzhaf A, Hempelmann G. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg. 2002 Jun;94(6):1521-9, table of contents. doi: 10.1097/00000539-200206000-00027.
PMID: 12032019RESULTWesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PMID: 30236233RESULTYu C, Gu J, Liao Z, Feng S. Prediction of spinal anesthesia-induced hypotension during elective cesarean section: a systematic review of prospective observational studies. Int J Obstet Anesth. 2021 Aug;47:103175. doi: 10.1016/j.ijoa.2021.103175. Epub 2021 May 1.
PMID: 34034957RESULT
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 29, 2024
First Posted
July 8, 2024
Study Start
July 31, 2024
Primary Completion
October 20, 2024
Study Completion
October 20, 2024
Last Updated
November 5, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share