ClearSight Monitoring for Epidural-Induced Low Blood Pressure

Overseen By Amy Monroe, MPH, MBA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Grace Lim, MD, MS

Must not be taking: Antihypertensives

Disqualifiers: Cardiac arrhythmias, Aortic regurgitation, Pre-eclampsia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring blood pressure in women receiving epidurals during labor. It compares the usual method with an additional device, the ClearSight HPI Monitoring system, to determine if it treats low blood pressure more quickly. The trial includes two groups: one using only the standard blood pressure cuff and the other using both the standard cuff and the ClearSight device. Pregnant women over 18 who are receiving an epidural for pain relief during labor may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance labor and delivery care.

Will I have to stop taking my current medications?

The trial excludes participants who are being treated with antihypertensive medications, so if you are taking these, you would not be eligible to participate.

What prior data suggests that the ClearSight Monitoring system is safe for use in laboring patients?

Studies have shown that the ClearSight Monitoring system, which uses the Hypotension Prediction Index (HPI), can help predict and prevent low blood pressure events. This system continuously monitors patients, alerting doctors early about possible drops in blood pressure. In some studies, about 41% of patients avoided low blood pressure with this system, compared to only 12% in other situations.

Research indicates that patients generally tolerate this predictive tool well. No significant reports of negative side effects from the ClearSight system itself have emerged. This suggests it is a safe option for monitoring blood pressure and helps healthcare providers respond more quickly to changes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to monitor blood pressure during epidural-induced hypotension. Unlike traditional methods that rely solely on a conventional blood pressure cuff, the ClearSight Monitoring system provides real-time data using a finger cuff. This could offer more precise and immediate insights into blood pressure changes, helping clinical staff respond more quickly to hypotensive events. By potentially improving monitoring accuracy, this approach could lead to better patient outcomes during epidurals.

What evidence suggests that the ClearSight Monitoring system is effective for managing epidural-induced low blood pressure?

Research has shown that the ClearSight monitoring system, tested in this trial, can better detect low blood pressure (hypotension). One study found that 41% of patients using the Acumen Hypotension Prediction Index (HPI) software, part of ClearSight, avoided low blood pressure, compared to only 12% of patients not using the software. The ClearSight system employs advanced technology to predict and alert healthcare providers about low blood pressure before it occurs. This enables faster treatment, potentially reducing the duration and severity of these events. The technology aims to improve patient health by ensuring quick management of blood pressure issues. ^{1 2 3 4 5}

Who Is on the Research Team?

Grace Lim, MD, MSc

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 or older who are receiving epidural labor analgesia. It's not suitable for those with non-reassuring fetal health, contraindications to epidurals, serious heart issues like arrhythmias or aortic regurgitation, high blood pressure treatments, pre-eclampsia, infections before surgery, or if the ClearSight device can't be used on them.

Inclusion Criteria

Pregnant

I am receiving pain relief through an epidural during labor.

Exclusion Criteria

The baby's heartbeat pattern is concerning when the request for electronic fetal monitoring is made.

I have serious heart rhythm problems or aortic valve issues.

I cannot undergo ELA due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive epidural labor analgesia and are monitored for hypotensive events using conventional and ClearSight monitoring systems

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of nausea, vomiting, and hypotension management

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• ClearSight HPI Monitoring system
• Standard of Care Blood Pressure Monitoring

Trial Overview The study is testing how well the ClearSight HPI Monitoring system works compared to standard blood pressure monitoring in managing low blood pressure during labor with an epidural. The goal is to see if this new system can detect and treat hypotension faster in healthy women giving birth.

How Is the Trial Designed?

Group I: ClearSight Monitoring Experimental Treatment 2 Interventions

Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Measures from BOTH the conventional blood pressure cuff and ClearSight monitoring system are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. ClearSight monitoring will add additional information regarding hypotensive events for clinical staff to respond to.

Group II: Conventional Care Placebo Group 1 Intervention

Patients are wearing both a conventional blood pressure cuff and the ClearSight finger cuff blood pressure monitoring system. Only measures from the conventional blood pressure cuff are sent/received by the clinical staff in the central and local nursing and anesthesia staff areas. The ClearSight monitoring system data is collected but not used by the clinical staff team for hypotensive monitoring.

Who Is Running the Clinical Trial?

Grace Lim, MD, MS

Lead Sponsor

Trials

10

Recruited

660+

Edwards Lifesciences

Industry Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Published Research Related to This Trial

The ClearSight System™ provides noninvasive continuous blood pressure measurements during anesthesia induction, showing potential as an alternative to traditional intra-arterial pressure monitoring in cardiovascular surgery.

In a study of 18 patients with 3068 paired measurements, the ClearSight System™ demonstrated a mean arterial pressure bias of -3.9 mmHg compared to invasive measurements, suggesting it could be a reliable method for monitoring blood pressure in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of noninvasive continuous arterial pressure measurement by ClearSight System™ during induction of anesthesia for cardiovascular surgery. Tanioku, T., Yoshida, A., Aratani, Y., et al.[2021]

The ClearSight system demonstrated good accuracy in measuring blood pressure during cesarean sections, with a bias of 8.8 mmHg for systolic and -6.3 mmHg for diastolic blood pressure when compared to invasive measurements from 21 patients.

This non-invasive method not only provided reliable blood pressure readings but also effectively monitored significant hemodynamic changes during and after the procedure, indicating its potential as a safe alternative to invasive monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Misugi, T., Juri, T., Suehiro, K., et al.[2022]

A study involving 31 women undergoing caesarean sections showed that the ClearSight® non-invasive blood pressure monitoring system provides reliable continuous measurements, with acceptable deviations from traditional methods.

Both patients and healthcare professionals preferred the ClearSight® system over conventional oscillometric methods for its comfort and ease of use, indicating its potential as a standard for monitoring during surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Non-Invasive Continuous Blood Pressure Measuring (ClearSight®) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. Helmer, P., Helf, D., Sammeth, M., et al.[2022]

The ClearSight™ system significantly reduced the incidence of hypotension during cesarean deliveries under spinal anesthesia, with rates dropping from 45% in the control group to 0% in the ClearSight group (p < 0.001).

Patients monitored with the ClearSight™ system experienced less intraoperative nausea (10% vs. 45% in the control group, p = 0.012), indicating improved safety and comfort during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of non-invasive continuous blood pressure monitoring on maternal hypotension during cesarean delivery: a randomized-controlled study. Juri, T., Suehiro, K., Kimura, A., et al.[2021]

In a study of 42 pregnant women undergoing elective cesarean delivery, hypotension occurred in 45% of cases, highlighting the common risk associated with spinal anesthesia.

The Clearsight™ device effectively predicted hypotension by analyzing stroke volume variation, achieving a high sensitivity of 87% and specificity of 83% with a cut-off value of 7%, making it a valuable tool for monitoring and preventing hypotension during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of non-invasive stroke volume variation during passive leg raising as a predictor of hypotension following induction of spinal anesthesia for elective cesarean delivery: a single cohort study. Duclos, G., Granier, S., Hili, A., et al.[2022]

In a study of 20 patients undergoing shoulder surgery in the beach chair position, the ClearSight™ system provided mean arterial pressure (MAP) measurements that were clinically acceptable when compared to traditional non-invasive blood pressure monitoring, with a mean difference of -0.9 mmHg in the beach chair position.

Despite the acceptable mean differences, the wide standard deviations and limits of agreement indicate variability in measurements, suggesting that while ClearSight™ is reliable, caution should be exercised in interpreting its readings during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive continuous blood pressure monitoring (ClearSight™ system) during shoulder surgery in the beach chair position: a prospective self-controlled study. Chachula, K., Lieb, F., Hess, F., et al.[2021]

Citations

1. edwards.com edwards.com/healthcare-professionals/products-services/predictive-monitoring/hpi

Acumen Hypotension Prediction Index software Low incidence of hypotension. 41% of patients avoided hypotension when monitored with Acumen HPI software, compared to 12% of patients in another large ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295593/

Feasibility of Hypotension Prediction Index-Guided Monitoring ... The primary efficacy outcome was time-to-treatment of hypotension, defined as the duration between onset of hypotension and administration of a vasopressor or ...

3. frontiersin.org frontiersin.org/journals/anesthesiology/articles/10.3389/fanes.2023.1138175/full

Hypotension prediction index: From reactive to ... This review describes the development and evaluation of an artificial intelligence predictive algorithm called Hypotension Prediction (HPI), which can predict ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06729827

Predictive Hemodynamic Monitoring During Elective ... The primary hypothesis is that hemodynamic management HPI-guided reduces the incidence, entity and duration of post-spinal hypotension, defined as mean arterial ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05906368/hypotension-prediction-index-to-predict-epidural-labor-analgesia-induced-hypotension?activelyRecruiting=false&page=283&id=172&slug=circulation-disorders

Hypotension Prediction Index to Predict Epidural-labor ... The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering ...