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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot trial is to examine the feasibility and ease of use of monitoring by ClearSight in laboring and delivering patients with the intent to compare time-to-treatment of hypotension between conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight, in a population of healthy laboring women who receive epidural analgesia.

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 data supports the effectiveness of the ClearSight Monitoring system for managing low blood pressure during epidural anesthesia?

Research shows that the ClearSight system, a non-invasive continuous blood pressure monitoring tool, is effective in reducing the incidence of low blood pressure during cesarean deliveries compared to traditional methods. It is also preferred by patients and professionals for its comfort and ease of use. ^{1 2 3 4 5}

Is the ClearSight Monitoring system safe for use in humans?

The ClearSight Monitoring system is generally considered safe for use in humans, as studies have shown it to be a reliable and non-invasive method for monitoring blood pressure during procedures like cesarean sections and cardiovascular surgeries. Patients and professionals have reported it to be comfortable and easy to handle compared to traditional methods. ^{1 2 3 4 6}

How does ClearSight Monitoring differ from standard blood pressure monitoring for epidural-induced low blood pressure?

ClearSight Monitoring is unique because it provides continuous, non-invasive blood pressure measurements using a finger cuff, which is more comfortable and avoids the need for invasive methods like arterial catheters. This system can offer more precise and immediate data compared to traditional oscillometric methods, potentially improving the management of low blood pressure during procedures like cesarean sections. ^{1 2 3 4 6}

Research Team

Grace Lim, MD, MSc

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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&#174;) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. Helmer, P., Helf, D., Sammeth, M., 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]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Impact of non-invasive continuous blood pressure monitoring on maternal hypotension during cesarean delivery: a randomized-controlled study. [2021]

2. Netherlands 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. [2022]

3. Korea (South) 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. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Non-Invasive Continuous Blood Pressure Measuring (ClearSight&#174;) during Central Neuraxial Anaesthesia for Caesarean Section-A Retrospective Validation Study. [2022]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Validation of noninvasive continuous arterial pressure measurement by ClearSight System™ during induction of anesthesia for cardiovascular surgery. [2021]