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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intraoperative Hypotension, Cesarean Section

Intervention / Treatment
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* Device: hypotension prediction index derived from non-invasive arterial pressure waveforms
* Device: non-invasive arterial pressure waveforms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20 - 50 year-old parturients scheduled cesarean delivery neuraxial anesthesia Exclusion Criteria: parturients with preeclampsia parturients with cardiovascular disease above NYHA functional class 2 parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases. severe perioperative arrhythmias with or without hemodynamic instability failed neuraxial anesthesia or regional blockade level below T6

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPI<br>Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and hypotension prediction index (HPI) derived from ClearSight are used for recording and monitoring. Blood pressure is monitored with ClearSight and HPI. Attending anesthesiologists controlled the blood pressure according to HPI values. Maintain HPI below 85 HPI > 85 and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg HPI > 85 and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg | Device: hypotension prediction index derived from non-invasive arterial pressure waveforms<br>* 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.<br>|
| Active Comparator: ClearSight<br>Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and HPI are masked for attending anesthesiologists. Blood pressure is monitored with ClearSight. Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg | Device: non-invasive arterial pressure waveforms<br>* 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.<br>|
| No Intervention: NIBP<br>Standard intraoperative monitor and non-invasive continuous arterial pressure waveforms (ClearSight) are set up in this group. ClearSight data and HPI derived from ClearSight are used for recording, and are masked for attending anesthesiologists. Blood pressure is monitored with conventional non-invasive blood pressure (NIBP). Attending anesthesiologists controlled the blood pressure according to continuous arterial pressure values. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-weighted MAP below 65 mmHg |  | through the surgery completion, an average of 1.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rates of parturients with intraoperative hypotension | hypotension is defined as MAP below 65 mmHg for more than 1 minute | through the surgery completion, an average of 1.5 hours | 
| total hypotension duration | hypotension is defined as MAP below 65 mmHg for more than 1 minute | through the surgery completion, an average of 1.5 hours | 
| area under curve of hypotension | hypotension is defined as MAP below 65 mmHg for more than 1 minute | through the surgery completion, an average of 1.5 hours | 
| total vasopressor dosage | average norepinephrine dosage used during the surgery | through the surgery completion, an average of 1.5 hours | 
| rate of hypotension related symptoms and sign of the parturients | symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering | through the surgery completion, an average of 1.5 hours | 
| average regional cerebral oxygen saturation |  | through the surgery completion, an average of 1.5 hours |