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

National Taiwan University

Status: Enrolling

Conditions: Cesarean Section; Intraoperative Hypotension

Treatments: Device: hypotension prediction index derived from non-invasive arterial pressure waveforms; Device: non-invasive arterial pressure waveforms

Study type: Interventional

Funder types: Other

Identifiers

NCT05667584

202210114RINC

Details and patient eligibility

About

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.

Enrollment: 255 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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255 participants in 3 patient groups

HPI

Experimental group

Description:

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. 1. Maintain HPI below 85 2. HPI \> 85 and heart rate \> 60/min, IV bolus norepinephrine 5-10 mcg 3. HPI \> 85 and heart rate \< 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg

Treatment:

Device: hypotension prediction index derived from non-invasive arterial pressure waveforms

ClearSight

Active Comparator group

Description:

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. 1. Maintain mean arterial pressure (MAP) above 65 mmHg 2. MAP \< 65mmHg and heart rate \> 60/min, IV bolus norepinephrine 5-10 mcg 3. MAP \< 65mmHg and heart rate \< 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg

Treatment:

Device: non-invasive arterial pressure waveforms

NIBP

No Intervention group

Description:

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. 1. Maintain mean arterial pressure (MAP) above 65 mmHg 2. MAP \< 65mmHg and heart rate \> 60/min, IV bolus norepinephrine 5-10 mcg 3. MAP \< 65mmHg and heart rate \< 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg