Clinical trial NCT05667584: Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Hypotension
Cesarean Section
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 255
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: time-weighted MAP below 65 mmHg
timeFrame: through the surgery completion, an average of 1.5 hours
Secondary outcomes:
measure: rates of parturients with intraoperative hypotension
timeFrame: through the surgery completion, an average of 1.5 hours
measure: total hypotension duration
timeFrame: through the surgery completion, an average of 1.5 hours
measure: area under curve of hypotension
timeFrame: through the surgery completion, an average of 1.5 hours
measure: total vasopressor dosage
timeFrame: through the surgery completion, an average of 1.5 hours
measure: rate of hypotension related symptoms and sign of the parturients
timeFrame: through the surgery completion, an average of 1.5 hours
measure: average regional cerebral oxygen saturation
timeFrame: through the surgery completion, an average of 1.5 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
citation: 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.
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.