NCT03918486

Brief Summary

Caretaker vs. routine blood pressure sphygmomanometer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

October 10, 2018

Last Update Submit

November 11, 2021

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Comparing blood pressure using routine blood pressure cuff to that recorded by the Caretaker device.

    As per blood pressure monitor validation guidelines, the primary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and the reference (brachial cuff). In line with the ANSI/ISO/AAMI guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (every 5 minutes during the surgical case) and will average the difference over all pairs from all subjects.

    Length of surgery

Study Arms (1)

Caretaker

Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Device: Caretaker

Interventions

CaretakerDEVICE

Application of Caretaker device to subjects that are scheduled for elective surgeries.

Caretaker

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults ages \> 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

You may qualify if:

  • Adults ages \> 18 who are having their blood pressure monitored using routine blood pressure sphygmomanometer.

You may not qualify if:

  • Patients not scheduled to be monitored using blood pressure sphygmomanometer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

April 17, 2019

Study Start

September 5, 2017

Primary Completion

November 9, 2021

Study Completion

November 10, 2021

Last Updated

November 12, 2021

Record last verified: 2021-11

Locations

US(1)