Intraoperative HypotensionNCT05667584
Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section
A study testing hypotension prediction index derived from non-invasive arterial pressure waveforms and non-invasive arterial pressure waveforms in people with Intraoperative Hypotension and Cesarean Section, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Intraoperative Hypotension, Cesarean Section
- What is being tested?
- hypotension prediction index derived from non-invasive arterial pressure waveforms and non-invasive arterial pressure waveforms
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20 - 50 year-old parturients
- scheduled cesarean delivery
- neuraxial anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Po-Yuan Shih
About this study
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
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.
- Conditions
- Intraoperative Hypotension, Cesarean Section
- Being tested
- hypotension prediction index derived from non-invasive arterial pressure waveforms, non-invasive arterial pressure waveforms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypotension prediction index derived from non-invasive arterial pressure waveformsDevice
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 waveformsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HPI | Experimental | 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 Receives: Device: hypotension prediction index derived from non-invasive arterial pressure waveforms |
| ClearSight | Active comparator | 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 Receives: Device: non-invasive arterial pressure waveforms |
| NIBP | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-weighted MAP below 65 mmHg
Measured: through the surgery completion, an average of 1.5 hours
Secondary outcomes (6)
rates of parturients with intraoperative hypotension
hypotension is defined as MAP below 65 mmHg for more than 1 minute
Measured: through the surgery completion, an average of 1.5 hours
total hypotension duration
hypotension is defined as MAP below 65 mmHg for more than 1 minute
Measured: through the surgery completion, an average of 1.5 hours
area under curve of hypotension
hypotension is defined as MAP below 65 mmHg for more than 1 minute
Measured: through the surgery completion, an average of 1.5 hours
total vasopressor dosage
average norepinephrine dosage used during the surgery
Measured: through the surgery completion, an average of 1.5 hours
rate of hypotension related symptoms and sign of the parturients
symptoms and signs include nausea, vomiting, bradycardia, dizziness, and shivering
Measured: through the surgery completion, an average of 1.5 hours
average regional cerebral oxygen saturation
Measured: through the surgery completion, an average of 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start13 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667584
- Sponsor's protocol ID
- 202210114RINC
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34591796Misugi 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.
PubMed 35754365
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05667584
- Acronym / sponsor ID
- 202210114RINC
- Conditions
- Intraoperative Hypotension, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HPI | Experimental | Device: hypotension prediction index derived from non-invasive arterial pressure waveformsStandard 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 |
| ClearSight | Active comparator | Device: non-invasive arterial pressure waveformsStandard 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 |
| NIBP | No intervention | –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 |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 - 50 year-old parturients
- scheduled cesarean delivery
- neuraxial anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypotension prediction index derived from non-invasive arterial pressure waveformsThe 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. | Device | HPI |
| non-invasive arterial pressure waveformsClearSight 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. | Device | ClearSight |
Primary outcome
time-weighted MAP below 65 mmHg
Time frame: through the surgery completion, an average of 1.5 hours
6 secondary outcomes
rates of parturients with intraoperative hypotension
Time frame: through the surgery completion, an average of 1.5 hours
total hypotension duration
Time frame: through the surgery completion, an average of 1.5 hours
area under curve of hypotension
Time frame: through the surgery completion, an average of 1.5 hours
total vasopressor dosage
Time frame: through the surgery completion, an average of 1.5 hours
rate of hypotension related symptoms and sign of the parturients
Time frame: through the surgery completion, an average of 1.5 hours
average regional cerebral oxygen saturation
Time frame: through the surgery completion, an average of 1.5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 34591796Frassanito 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.
- Background: PubMed 35754365Misugi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypotension prediction index derived from non-invasive arterial pressure waveforms and non-invasive arterial pressure waveforms in people with Intraoperative Hypotension and Cesarean Section, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Yuan Shih, MD (886-2-23123456 ext. 262158, shih.poyuan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time-weighted MAP below 65 mmHg (time frame: through the surgery completion, an average of 1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05667584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.