Cesarean Section, Intraoperative Hypotension
Conditions
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.
Interventions
DEVICEhypotension 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.
DEVICEnon-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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time-weighted MAP below 65 mmHg | through the surgery completion, an average of 1.5 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total hypotension duration | through the surgery completion, an average of 1.5 hours | hypotension is defined as MAP below 65 mmHg for more than 1 minute |
| area under curve of hypotension | through the surgery completion, an average of 1.5 hours | hypotension is defined as MAP below 65 mmHg for more than 1 minute |
| rates of parturients with intraoperative hypotension | through the surgery completion, an average of 1.5 hours | hypotension is defined as MAP below 65 mmHg for more than 1 minute |
| rate of hypotension related symptoms and sign of the parturients | through the surgery completion, an average of 1.5 hours | symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering |
| average regional cerebral oxygen saturation | through the surgery completion, an average of 1.5 hours | — |
| total vasopressor dosage | through the surgery completion, an average of 1.5 hours | average norepinephrine dosage used during the surgery |
Countries
Taiwan
Contacts
Primary ContactPo-Yuan Shih, MD
Outcome results
None listed