Anesthesia, EpiduralNCT05906368

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

A study testing ClearSight HPI Monitoring system in people with Anesthesia, Epidural and Hypotension, run by Grace Lim, MD, MS at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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… Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Anesthesia, Epidural, Hypotension
What is being tested?: ClearSight HPI Monitoring system
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2024to 29 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Pregnant
Age ≥ 18 years of age
Planning vaginal delivery
Receiving epidural labor analgesia (ELA)

Who cannot join

Non-reassuring fetal tracing at the time of ELA request
Contraindications to ELA
Significant cardiac arrhythmias or aortic regurgitation
Arrhythmia
Treatment with antihypertensive medications
Pre-eclampsia with or without severe features

Show all 11Show fewer

Preoperative infection
Inability to use ClearSight device for any reason
Non-English fluency
Sustains unintentional dural puncture
Incomplete data

Trial locations and contacts

1 site in 1 country.

United States1 site

Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study

Read the detailed description

In a prospective study, we will achieve the following aims:

To determine the feasibility and ease of use of the ClearSight monitoring system in the labor-delivery room (LDR) in detecting and monitoring hypotensive events post-epidural labor analgesia placement.

To compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.

Conditions: Anesthesia, Epidural, Hypotension
Being tested: ClearSight HPI Monitoring system, Standard of Care Blood Pressure Monitoring
Medical subject headings: Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClearSight HPI Monitoring systemDiagnostic test
Continuous blood pressure monitoring for precision hypotensive event response
Standard of Care Blood Pressure MonitoringDiagnostic test
Blood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.

Study groups in NCT05906368
Study group	Role	What they receive
Conventional Care	Sham comparator	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. Receives: Diagnostic Test: Standard of Care Blood Pressure Monitoring
ClearSight Monitoring	Experimental	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. Receives: Diagnostic Test: ClearSight HPI Monitoring system; Diagnostic Test: Standard of Care Blood Pressure Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

Time-to-treatment of Hypotension (Minutes)
The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
Measured: From epidural placement until 4-hours post-infusion start
Ease of Use by Clinical Staff
Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems easy to use."
Measured: report at 4-hour post-infusion
Ease of Hypotension Detection by Clinical Staff
Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems suitable."
Measured: report at 4-hour post-infusion
Satisfaction of ClearSight Use by Clinical Staff
Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device meets my approval."
Measured: report at 4-hour post-infusion

Secondary outcomes (8)

Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)
Average number of minutes patients spent within hypotensive events for each group (CM and CM + HPI).
Measured: Epidural placement to 4-hours post-infusion start
Nausea (Yes/No)
Proportion of patients by group reporting nausea within 4-hours of post-epidural placement
Measured: Epidural placement to 4-hours post-infusion start
Vomiting (Yes/No)
Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement
Measured: Epidural placement to 4-hours post-infusion start
Total Phenylephrine, mg
Average phenylephrine dose(s) given to patients in CM and CM+HPI groups
Measured: Epidural placement to 4-hours post-infusion start
Total Ephedrine, mg
Average ephedrine dose(s) given to patients in CM and CM+HPI groups
Measured: Epidural placement to 4-hours post-infusion start
Total Intravenous Fluids, mL
Average volume of fluids given to patients in CM and CM+HPI groups
Measured: Epidural placement to 4-hours post-infusion start
Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)
Total number of participants who experienced changes in fetal heart rate category (any)
Measured: Epidural placement to 4-hours post-infusion start
Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA
Percentage of patients who experience any fetal heart rate deceleration event [Presence (Yes) or absence (No)] within 1-hour of epidural placement.
Measured: Epidural placement to 1-hour post-infusion start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 202429 Aug 2024

First posted15 Jun 2023
Study start18 Apr 2024
Primary completion29 Aug 2024
Study completion29 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anesthesia, EpiduralStudies of the same condition, open and under way.
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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.
Masking: Single blind
Who is masked: Participant
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05906368
Sponsor's protocol ID: STUDY23030009
Status last verified: Aug 2025
First submitted: 8 May 2023
Last updated: 4 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery

All Anesthesia, Epidural trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension -- Pilot Study
ClinicalTrials.gov ID: NCT05906368
Acronym / sponsor ID: STUDY23030009
Conditions: Anesthesia, Epidural, Hypotension
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Grace Lim, MD, MSUniversity, hospital or other
Collaborators: Edwards Lifesciences
Study start: 18 Apr 2024 (actual)
Primary completion: 29 Aug 2024 (actual)
Study completion: 29 Aug 2024 (actual)
First posted: 15 Jun 2023 (actual)
Results: Posted 4 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In a prospective study, we will achieve the following aims:

To compare the Time-to-Treatment of hypotensive events between the conventionally monitored patients (Group CM) and those receiving HPI (Group CM + HPI) monitoring by ClearSight.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.

Arm	Type	Receives
Conventional Care	Sham comparator	Diagnostic Test: Standard of Care Blood Pressure MonitoringPatients 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.
ClearSight Monitoring	Experimental	Diagnostic Test: ClearSight HPI Monitoring system, Diagnostic Test: Standard of Care Blood Pressure MonitoringPatients 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Pregnant
Age ≥ 18 years of age
Planning vaginal delivery
Receiving epidural labor analgesia (ELA)

Key exclusion criteria (11 listed)

Non-reassuring fetal tracing at the time of ELA request
Contraindications to ELA
Significant cardiac arrhythmias or aortic regurgitation
Arrhythmia
Treatment with antihypertensive medications

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
ClearSight HPI Monitoring systemContinuous blood pressure monitoring for precision hypotensive event response	Diagnostic test	ClearSight Monitoring
Standard of Care Blood Pressure MonitoringBlood pressure (BP) monitoring using a conventional arm cuff and inflation after epidural anesthesia as standard procedure. Standard of care blood pressure monitoring includes measurement of blood pressure at the time of epidural test dose delivery, 3-minute cycles of BP monitoring for 30 minutes after epidural placement, and then BP monitoring every 15 minutes per existing clinical standards for at least 4-hours, or until delivery.	Diagnostic test	ClearSight Monitoring, Conventional Care

Primary outcome

Time-to-treatment of Hypotension (Minutes)
Time frame: From epidural placement until 4-hours post-infusion start
The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups
Ease of Use by Clinical Staff
Time frame: report at 4-hour post-infusion
Clinical nurse reports of ease of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems easy to use."
Ease of Hypotension Detection by Clinical Staff
Time frame: report at 4-hour post-infusion
Clinical nurse reports of ease of hypotension detection using ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device seems suitable."
Satisfaction of ClearSight Use by Clinical Staff
Time frame: report at 4-hour post-infusion
Clinical nurse reports of satisfaction of use of ClearSight device. This outcome will be measured on a Likert Scale (0-4) with the options being: 0-Completely Disagree, 1-Disagree, 2-Neither agree nor disagree, 3-Agree, 4-Completely Agree. Outcome measure will be reported as count of participant's responses per category. For this scale, the objective was to obtain agreeable response feedback (score of 3 or 4). The specific question to measure ease of use by clinical staff was: "The ClearSight blood pressure monitoring device meets my approval."

8 secondary outcomes

Total Time in Hypotension With Mean Arterial Pressure (MAP) <65 mmHg (in Minutes)
Time frame: Epidural placement to 4-hours post-infusion start
Nausea (Yes/No)
Time frame: Epidural placement to 4-hours post-infusion start
Vomiting (Yes/No)
Time frame: Epidural placement to 4-hours post-infusion start
Total Phenylephrine, mg
Time frame: Epidural placement to 4-hours post-infusion start
Total Ephedrine, mg
Time frame: Epidural placement to 4-hours post-infusion start
Total Intravenous Fluids, mL
Time frame: Epidural placement to 4-hours post-infusion start
Total Number of Reported Changes in Fetal Heart Rate Category (From Healthy to Deceleration or Excelleration)
Time frame: Epidural placement to 4-hours post-infusion start
Fetal Heart Rate Decelerations Within 1 Hour of Initiation of ELA
Time frame: Epidural placement to 1-hour post-infusion start

Results and safety

Results posted to the registry on 4 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional Care	17	14
ClearSight Monitoring	17	16

Primary outcome: Time-to-treatment of Hypotension (Minutes)

Time frame: From epidural placement until 4-hours post-infusion start. Mean (Standard Deviation). Unit: minutes

Measure	Conventional Care n = 10	ClearSight Monitoring n = 10
Value	21.8 (17.5)	23.1 (17.6)

Population analysed: Only subjects with a hypotensive event were analyzed for this outcome measure (n=20)

Primary outcome: Ease of Use by Clinical Staff

Time frame: report at 4-hour post-infusion. Count of participants. Unit: Participants

Measure	Conventional Care n = 14	ClearSight Monitoring n = 16
Disagree	1	1
Neither agree nor disagree	4	4
Agree	6	7
Completely Agree	3	4

Primary outcome: Ease of Hypotension Detection by Clinical Staff

Time frame: report at 4-hour post-infusion. Count of participants. Unit: Participants

Measure	Conventional Care n = 14	ClearSight Monitoring n = 16
Disagree	1	1
Completely Agree	4	3
Neither agree nor disagree	0	2
Agree	9	10

Primary outcome: Satisfaction of ClearSight Use by Clinical Staff

Time frame: report at 4-hour post-infusion. Count of participants. Unit: Participants

Measure	Conventional Care n = 14	ClearSight Monitoring n = 16
Disagree	1	0
Completely Agree	5	5
Agree	7	8
Neither agree nor disagree	1	3

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36+ weeks gestation to 12-weeks postpartum per subject. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conventional Care	0 of 14 (0%)	0 of 14 (0%)	0 of 14
ClearSight Monitoring	0 of 16 (0%)	0 of 16 (0%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Anesthesia, Epidural

RecruitingObservational study
Epidural Hydroxyethyl Starch for Post-Dural Puncture Headache in Parturients
Parturients, Accidental Puncture of Dura During Anaesthesia
RecruitingPhase 2/3
Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
Postdural Puncture Headache (PDPH)
Recruiting
Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Pregnancy
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery

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.

Grace Lim, MD, MSc principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ClearSight HPI Monitoring system in people with Anesthesia, Epidural and Hypotension, run by Grace Lim, MD, MS at 1 site in United States.

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 4 inclusion and 11 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: finished, as of the sponsor's last update on 4 Nov 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time-to-treatment of Hypotension (Minutes) (time frame: From epidural placement until 4-hours post-infusion start). The study lists 4 primary outcomes in all. 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 NCT05906368.

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 4 Nov 2025.