Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section
NCT ID: NCT05667584
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
255 participants
INTERVENTIONAL
2023-01-13
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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
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.
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.
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
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.
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.
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
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* scheduled cesarean delivery
* neuraxial anesthesia
Exclusion Criteria
* 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
20 Years
50 Years
FEMALE
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Po-Yuan Shih
Role: primary
References
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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.
Other Identifiers
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202210114RINC
Identifier Type: -
Identifier Source: org_study_id