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

Oregon Health & Science University (OHSU)

Status: Terminated

Conditions: Critically Ill

Treatments: Device: T-line hemodynamic monitoring device (placement and use)

Study type: Observational

Funder types: Other

Identifiers

NCT01311128

6980 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

31 participants in 1 patient group

Heart rate and blood pressure determination

Description:

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

Treatment:

Device: T-line hemodynamic monitoring device (placement and use)