Trial Outcomes & Findings for Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension (NCT NCT05906368)

Results Overview

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."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

report at 4-hour post-infusion

Results posted on

2025-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Conventional Care 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. Standard of Care Blood Pressure Monitoring: 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.	ClearSight Monitoring 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. ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response Standard of Care Blood Pressure Monitoring: 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.
Overall Study STARTED	17	17
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Conventional Care 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. Standard of Care Blood Pressure Monitoring: 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.	ClearSight Monitoring 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. ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response Standard of Care Blood Pressure Monitoring: 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.
Overall Study Withdrawal by Subject	1	1
Overall Study Ineligibility criteria identified	2	0

Baseline Characteristics

Hypotension Prediction Index to Predict Epidural-labor Analgesia Induced Hypotension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Care n=14 Participants 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. Standard of Care Blood Pressure Monitoring: 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.	ClearSight Monitoring n=16 Participants 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. ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response Standard of Care Blood Pressure Monitoring: 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.	Total n=30 Participants Total of all reporting groups
Age, Continuous	29.4 years STANDARD_DEVIATION 5.5 • n=15 Participants	29.8 years STANDARD_DEVIATION 5.7 • n=161 Participants	29.6 years STANDARD_DEVIATION 5.5 • n=100 Participants
Sex: Female, Male Female	14 Participants n=15 Participants	16 Participants n=161 Participants	30 Participants n=100 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Asian	1 Participants n=15 Participants	0 Participants n=161 Participants	1 Participants n=100 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants	3 Participants n=161 Participants	4 Participants n=100 Participants
Race (NIH/OMB) White	12 Participants n=15 Participants	13 Participants n=161 Participants	25 Participants n=100 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants
Region of Enrollment United States	14 participants n=15 Participants	16 participants n=161 Participants	30 participants n=100 Participants
Body Mass Index	32.4 kg/m^2 STANDARD_DEVIATION 5.1 • n=15 Participants	34.9 kg/m^2 STANDARD_DEVIATION 6.3 • n=161 Participants	33.7 kg/m^2 STANDARD_DEVIATION 5.8 • n=100 Participants

PRIMARY outcome

Timeframe: From epidural placement until 4-hours post-infusion start

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

The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups

Outcome measures

Outcome measures
Measure	Conventional Care n=10 Participants 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. Standard of Care Blood Pressure Monitoring: 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.	ClearSight Monitoring n=10 Participants 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. ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response Standard of Care Blood Pressure Monitoring: 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.
Time-to-treatment of Hypotension (Minutes)	21.8 minutes Standard Deviation 17.5	23.1 minutes Standard Deviation 17.6

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Conventional Care n=14 Participants 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. Standard of Care Blood Pressure Monitoring: 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.	ClearSight Monitoring n=16 Participants 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. ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response Standard of Care Blood Pressure Monitoring: 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.
Ease of Use by Clinical Staff Disagree	1 Participants	1 Participants
Ease of Use by Clinical Staff Neither agree nor disagree	4 Participants	4 Participants
Ease of Use by Clinical Staff Agree	6 Participants	7 Participants
Ease of Use by Clinical Staff Completely Agree	3 Participants	4 Participants

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	Conventional Care n=14 Participants 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. Standard of Care Blood Pressure Monitoring: 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.	ClearSight Monitoring n=16 Participants 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. ClearSight HPI Monitoring system: Continuous blood pressure monitoring for precision hypotensive event response Standard of Care Blood Pressure Monitoring: 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.
Ease of Hypotension Detection by Clinical Staff Disagree	1 Participants	1 Participants
Ease of Hypotension Detection by Clinical Staff Completely Agree	4 Participants	3 Participants
Ease of Hypotension Detection by Clinical Staff Neither agree nor disagree	0 Participants	2 Participants
Ease of Hypotension Detection by Clinical Staff Agree	9 Participants	10 Participants

PRIMARY outcome

Timeframe: 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."