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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05667584
• Other study ID #: 202210114RINC
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: National Taiwan University Hospital
• Contact: Po-Yuan Shih, MD
• Phone: 886-2-23123456
• Email: shih.poyuan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 255
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension
• Intraoperative Hypotension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

Frassanito L, Sonnino C, Piersanti A, Zanfini BA, Catarci S, Giuri PP, Scorzoni M, Gonnella GL, Antonelli M, Draisci G. Performance of the Hypotension Prediction Index With Noninvasive Arterial Pressure Waveforms in Awake Cesarean Delivery Patients Under Spinal Anesthesia. Anesth Analg. 2022 Mar 1;134(3):633-643. doi: 10.1213/ANE.0000000000005754. — View Citation

Misugi T, Juri T, Suehiro K, Kitada K, Kurihara Y, Tahara M, Hamuro A, Nakano A, Koyama M, Mori T, Tachibana D. Non-invasive continuous blood pressure monitoring using the ClearSight system for pregnant women at high risks of post-partum hemorrhage: comparison with invasive blood pressure monitoring during cesarean section. Obstet Gynecol Sci. 2022 Jul;65(4):325-334. doi: 10.5468/ogs.22063. Epub 2022 Jun 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time-weighted MAP below 65 mmHg		through the surgery completion, an average of 1.5 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	total vasopressor dosage	average norepinephrine dosage used during the surgery	through the surgery completion, an average of 1.5 hours
Secondary	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
Secondary	average regional cerebral oxygen saturation		through the surgery completion, an average of 1.5 hours