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

Last updated: December 25, 2023
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Vascular Diseases

Dizzy/fainting Spells

Treatment

hypotension prediction index derived from non-invasive arterial pressure waveforms

non-invasive arterial pressure waveforms

Clinical Study ID

NCT05667584
202210114RINC
  • Ages 20-50
  • Female

Study 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

Inclusion Criteria:

  • 20 - 50 year-old parturients
  • scheduled cesarean delivery
  • neuraxial anesthesia

Exclusion

Exclusion Criteria:

  • parturients with preeclampsia
  • parturients with cardiovascular disease above NYHA functional class 2
  • parturients with arrhythmias, preoperative severe hypertension, or other severecardiopulmonary diseases.
  • severe perioperative arrhythmias with or without hemodynamic instability
  • failed neuraxial anesthesia or regional blockade level below T6

Study Design

Total Participants: 255
Treatment Group(s): 2
Primary Treatment: hypotension prediction index derived from non-invasive arterial pressure waveforms
Phase:
Study Start date:
January 13, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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