Clinical trial NCT06825806: Doppler Indices to Predict Spinal Hypotension During Cesarean Section
Official title: Femoral Artery Doppler Indices as an Emerging Predictor of Spinal Anesthesia-induced Hypotension in Elective Cesarean Section: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Hypotension
Doppler
Keywords: Spinal hypotension; Cesarean section; femoral Doppler
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women undergoing cesarean section

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* ASA II
* singleton pregnancy
* full term

Exclusion Criteria:

* vascular disease
* contraindication to spinal anesthesia
* inability to obtain adequate Doppler

Primary outcomes:
measure: Accuracy of the change in pulsatility index to predict spinal hypotension
timeFrame: baseline and immediately after spinal anesthesia
Secondary outcomes:
measure: accuracy of change in waveform morphology to predict spinal hypotension
timeFrame: baseline and immediately after spinal anesthesia
measure: baseline shock index to predict hypotension
timeFrame: baseline
measure: baseline PI to predict spinal hypotension
timeFrame: baseline
measure: baseline RI to predict hypotension
timeFrame: baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: Giza Governorate
Study officials:
affiliation: Cairo University
name: Helmy
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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 Apr;44(2):101482. doi: 10.1016/j.accpm.2025.101482. Epub 2025 Jan 21. No abstract available.
citation: 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.
citation: 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.