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Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

Primary Purpose

Critically Ill

Status

Terminated

Phase

Locations

United States

Study Type

Observational

Intervention

T-line hemodynamic monitoring device (placement and use)

About this trial

This is an observational trial for Critically Ill focused on measuring Blood pressure, Heart rate, Cardiac output, Critical care, Perioperative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age at least 18 years old
Operative patients expected to require intensive care recovery at OHSU
Planned or existing intra- and postoperative radial artery catheterization as part of routine care
Palpable contralateral (to catheter) radial artery pulse
Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total

Exclusion Criteria:

No palpable radial artery pulse
Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site
An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor
An AV shunt in the T-line arm
Known sensitivity to pressure stimuli (dermatographism)

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Arm Label

Heart rate and blood pressure determination

Arm Description

All subjects have the same conditions (T-line, blood pressure cuff, and radial artery catheter), in order to compare them within-subjects.

Outcomes

Primary Outcome Measures

Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure

Secondary Outcome Measures

Agreement between the T-line and right heart catheter in determining cardiac output

Full Information

NCT ID

NCT01311128

First Posted

March 8, 2011

Last Updated

August 23, 2019

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01311128

Brief Title

Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

Official Title

Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

Study Type

Observational

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Terminated

Why Stopped

PI left institution

Study Start Date

February 16, 2011 (Actual)

Primary Completion Date

June 29, 2012 (Actual)

Study Completion Date

December 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This protocol will test a new non-invasive device, the T-line, in continuously determining heart rate and blood pressure in operative and critically ill patients. The accuracy of the device will be compared to the standard radial artery catheter, as well as to the non-invasive blood pressure cuff. The T-line will also be compared to the right heart catheter determining cardiac output in at least 20 patients. Hypothesis: the T-line device will determine blood pressure and heart rate as accurately as a standard radial arterial catheter and a blood pressure cuff in perioperative patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill

Keywords

Blood pressure, Heart rate, Cardiac output, Critical care, Perioperative care

7. Study Design

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heart rate and blood pressure determination

Arm Description

All subjects have the same conditions (T-line, blood pressure cuff, and radial artery catheter), in order to compare them within-subjects.

Intervention Type

Device

Intervention Name(s)

T-line hemodynamic monitoring device (placement and use)

Other Intervention Name(s)

T-line, Tensymeter, Tensys Medical, Inc., Hemodynamic monitoring

Intervention Description

The T-line device will be placed over the contralateral (from the radial artery catheter) radial artery at the distal wrist. To attach the device, a single-use sterile sensor is placed over the radial artery and the device then gently clamped around the wrist to incorporate the sensor. After a ten-minute stabilization period, data will be recorded every ten minutes during the first two hours of surgery, or until the patient is placed on cardiopulmonary bypass. The T-line device will then be removed. This procedure will be repeated, for a second two-hour period, in the ICU postoperatively.

Primary Outcome Measure Information:

Title

Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure

Time Frame

Assessed 24 times over four hours

Secondary Outcome Measure Information:

Title

Agreement between the T-line and right heart catheter in determining cardiac output

Time Frame

Assessed every 30 minutes over four hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age at least 18 years old Operative patients expected to require intensive care recovery at OHSU Planned or existing intra- and postoperative radial artery catheterization as part of routine care Palpable contralateral (to catheter) radial artery pulse Planned intraoperative right heart catheter placement as part of routine clinical care, in at least 20 subjects of total Exclusion Criteria: No palpable radial artery pulse Anatomical abnormalities (skin grafts, cysts, cellulitis) or injuries (scarring, cuts, burns, bruising) at the sensor site An intravenous line placed at the sensor application site or within the medial/lateral travel range of the sensor An AV shunt in the T-line arm Known sensitivity to pressure stimuli (dermatographism)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Phillips, MD

Organizational Affiliation

503-494-2465

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Determination of the Accuracy of a Non-Invasive Continuous Blood Pressure Device

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