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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearSight HPI Monitoring system | Diagnostic Test | Continuous blood pressure monitoring for precision hypotensive event response |
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| Measure | Description | Time Frame |
|---|---|---|
| Time-to-treatment of Hypotension (Minutes) | The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups | 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." | 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." | 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Epidural placement to 4-hours post-infusion start |
| Nausea (Yes/No) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Lim, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time-to-treatment of Hypotension (Minutes) | The difference in time between diagnosis of hypotension and treatment by clinical staff between CM and HPI groups | Only subjects with a hypotensive event were analyzed for this outcome measure (n=20) | Posted | Mean | Standard Deviation | minutes | From epidural placement until 4-hours post-infusion start |
|
36+ weeks gestation to 12-weeks postpartum per subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katherine Grace Lim | UPMC, University of Pittsburgh | 412-641-1778 | limkg2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2024 | Oct 6, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 7, 2024 | Jun 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Participants are randomized to receive standard clinical care (SCC) blood pressure measurement or blood pressure monitoring of HPI via ClearSight with SCC.
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Participants will wear both a conventional blood pressure cuff and the ClearSight finger cuff throughout the duration of the 4-hours post-epidural placement.
| Standard of Care Blood Pressure Monitoring | Diagnostic 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. |
|
| report at 4-hour post-infusion |
Proportion of patients by group reporting nausea within 4-hours of post-epidural placement |
| 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 | Epidural placement to 4-hours post-infusion start |
| Total Phenylephrine, mg | Average phenylephrine dose(s) given to patients in CM and CM+HPI groups | Epidural placement to 4-hours post-infusion start |
| Total Ephedrine, mg | Average ephedrine dose(s) given to patients in CM and CM+HPI groups | 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 | 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) | 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. | Epidural placement to 1-hour post-infusion start |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| OG001 | 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. |
|
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| Primary | 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." | Posted | Count of Participants | Participants | report at 4-hour post-infusion |
|
|
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| Primary | 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." | Posted | Count of Participants | Participants | report at 4-hour post-infusion |
|
|
|
| Primary | 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." | Posted | Count of Participants | Participants | report at 4-hour post-infusion |
|
|
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| Secondary | 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). | Posted | Mean | Standard Deviation | minutes | Epidural placement to 4-hours post-infusion start |
|
|
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| Secondary | Nausea (Yes/No) | Proportion of patients by group reporting nausea within 4-hours of post-epidural placement | Posted | Count of Participants | Participants | Epidural placement to 4-hours post-infusion start |
|
|
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| Secondary | Vomiting (Yes/No) | Proportion of patients by group reporting Vomiting within 4-hours of post-epidural placement | Posted | Count of Participants | Participants | Epidural placement to 4-hours post-infusion start |
|
|
|
| Secondary | Total Phenylephrine, mg | Average phenylephrine dose(s) given to patients in CM and CM+HPI groups | Only subjects with a hypotensive event and received phenylephrine were analyzed for this outcome measure (n=9) | Posted | Mean | Standard Deviation | mg | Epidural placement to 4-hours post-infusion start |
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|
| Secondary | Total Ephedrine, mg | Average ephedrine dose(s) given to patients in CM and CM+HPI groups | Only subjects with a hypotensive event and received epinephrine were analyzed for this outcome measure (n=19) | Posted | Mean | Standard Deviation | mg | Epidural placement to 4-hours post-infusion start |
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| Secondary | Total Intravenous Fluids, mL | Average volume of fluids given to patients in CM and CM+HPI groups | Only subjects with a hypotensive event and received IV fluids were analyzed for this outcome measure (n=16) | Posted | Mean | Standard Deviation | mL | Epidural placement to 4-hours post-infusion start |
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| Secondary | 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) | Posted | Count of Participants | Participants | Epidural placement to 4-hours post-infusion start |
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| Secondary | 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. | Posted | Count of Participants | Participants | Epidural placement to 1-hour post-infusion start |
|
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|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
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| Agree |
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| Completely Agree |
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| Neither agree nor disagree |
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| Agree |
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| Agree |
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| Neither agree nor disagree |
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