Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HPI 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. Maintain HPI below 85 HPI > 85 and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg HPI > 85 and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg |
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.
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| Active Comparator: ClearSight 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. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg |
Device: 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.
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| No Intervention: NIBP 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. Maintain mean arterial pressure (MAP) above 65 mmHg MAP < 65mmHg and heart rate > 60/min, IV bolus norepinephrine 5-10 mcg MAP < 65mmHg and heart rate < 60/min, IV bolus norepinephrine 5-10 mcg with atropine 0.01 mg/kg |
Outcome Measures
Primary Outcome Measures
- time-weighted MAP below 65 mmHg [through the surgery completion, an average of 1.5 hours]
Secondary Outcome Measures
- 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
- 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
- total vasopressor dosage [through the surgery completion, an average of 1.5 hours]
average norepinephrine dosage used during the surgery
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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20 - 50 year-old parturients
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scheduled cesarean delivery
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neuraxial anesthesia
Exclusion Criteria:
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parturients with preeclampsia
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parturients with cardiovascular disease above NYHA functional class 2
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parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases.
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severe perioperative arrhythmias with or without hemodynamic instability
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failed neuraxial anesthesia or regional blockade level below T6
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 202210114RINC