NCT05667584

Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

Comparisons of the Blood Pressure Control Ability Between Hypotension Prediction Index With Non-invasive Continuous Arterial Pressure Waveforms, Continuous Blood Pressure Monitoring With Non-invasive Continuous Arterial Pressure Waveforms, and Intermittent Blood Pressure Monitoring With Conventional Non-invasive Blood Pressureduring Neuraxial Anesthesia in Cesarean Section: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare the blood pressure control ability with HPI, ClearSight, and conventional NIBP during neuraxial anesthesia in cesarean section. The main question it aims to answer is: Anesthesiologists can have a better control of blood pressure during cesarean section with HPI than with conventional NIBP. During the surgery, the participants will be monitored with standard monitor and HPI with ClearSight and will be randomly assigned to three groups, including HPI group, ClearSight group, and NIBP group. Anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. Investigators will compare the time-weighted average mean arterial pressure \< 65mmHg with in three groups. Secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.

Conditions

• Intraoperative Hypotension
• Cesarean Section

Interventions

Type	Name	Description
DEVICE	hypotension prediction index derived from non-invasive arterial pressure waveforms	The Hypotension Prediction Index (HPI) is an algorithm based on the complex analysis of features in high-fidelity arterial pressure waveform recordings developed to observe subtle signs that could predict the onset of hypotension in surgical and intensive care unit patients. HPI is a unitless number that ranges from 1 to 100, and as the number increases, the likelihood of a hypotensive event (MAP \<65 mm Hg for more than 1 minute) occurring in the near future increases. In a validation study on HPI conducted in patients under general anesthesia, the algorithm, at its optimal value, predicted hypotension with both sensitivity and specificity of 86% 5 minutes before the event. Measurement of the arterial pressure waveforms using a finger cuff (ClearSight) is well established.
DEVICE	non-invasive arterial pressure waveforms	ClearSight is a non-invasive hemodynamic monitoring device using digital-cuff and volume-clamp technology to obtain a continuous arterial blood pressure waveform. Continuous finger blood pressure measurement is established by wrapping the cuff around the middle phalanx of a finger. The area under the waveform curve is analyzed using a unique algorithm that serves to calculate the arterial blood pressure, stroke volume (SV) and CO.

Timeline

• Start date: 2023-01-13
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-12-28
• Last updated: 2023-12-27

Locations

1 site across 1 country: Taiwan