Doppler Indices to Predict Spinal Hypotension During Cesarean Section
April 3, 2025 updated by: Mina Adolf Helmy, Cairo University
Femoral Artery Doppler Indices as an Emerging Predictor of Spinal Anesthesia-induced Hypotension in Elective Cesarean Section: A Prospective Observational Study
Spinal anesthesia is safe and advisable anesthetic during cesarean section, despite that spinal induced hypotension is a common associated problem.
Therefore early recognition of these critical events should take high priority to avoid serious consequences.
in this regards several parameters were available to detect spinal hypotension but non is satisfactory till now.
Researchers of this study aimed to evaluated the diagnostic accuracy of femoral artery Doppler to predict hypotension
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
-
-
Giza Governorate
-
Cairo, Giza Governorate, Egypt, 6890
- Cairo 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
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Pregnant women undergoing cesarean section
Description
Inclusion Criteria:
- ASA II
- singleton pregnancy
- full term
Exclusion Criteria:
- vascular disease
- contraindication to spinal anesthesia
- inability to obtain adequate Doppler
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 |
|---|---|
|
Accuracy of the change in pulsatility index to predict spinal hypotension
Time Frame: baseline and immediately after spinal anesthesia
|
baseline and immediately after spinal anesthesia
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
accuracy of change in waveform morphology to predict spinal hypotension
Time Frame: baseline and immediately after spinal anesthesia
|
baseline and immediately after spinal anesthesia
|
|
baseline shock index to predict hypotension
Time Frame: baseline
|
baseline
|
|
baseline PI to predict spinal hypotension
Time Frame: baseline
|
baseline
|
|
baseline RI to predict hypotension
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helmy, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
- Yu 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.
- Kim ES, Sharma AM, Scissons R, Dawson D, Eberhardt RT, Gerhard-Herman M, Hughes JP, Knight S, Marie Kupinski A, Mahe G, Neumyer M, Poe P, Shugart R, Wennberg P, Williams DM, Zierler RE. Interpretation of peripheral arterial and venous Doppler waveforms: A consensus statement from the Society for Vascular Medicine and Society for Vascular Ultrasound. Vasc Med. 2020 Oct;25(5):484-506. doi: 10.1177/1358863X20937665. Epub 2020 Jul 15.
- Adolf Helmy M, Mansour M, Magdy Milad L, Mohammed Aboelregal E, Magdy Youssef M. Change in femoral artery pulsatility index as a novel predictor of post-spinal anesthesia hypotension in adult patients undergoing infra-umbilical surgeries: A prospective observational study. Anaesth Crit Care Pain Med. 2025 Jan 21;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Online ahead of print. No abstract available.
Helpful Links
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 14, 2025
Primary Completion (Actual)
April 3, 2025
Study Completion (Actual)
April 3, 2025
Study Registration Dates
First Submitted
February 8, 2025
First Submitted That Met QC Criteria
February 8, 2025
First Posted (Actual)
February 13, 2025
Study Record Updates
Last Update Posted (Actual)
April 6, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doppler and spinal hypotension
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Data regarding this research will be available from the corresponding author upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.