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

Critically Ill Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01311128
• Other study ID #: 6980
• Status: Terminated
• Start date: February 16, 2011
• Est. completion date: December 30, 2014

Study information

• Verified date: August 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: December 30, 2014
• Est. primary completion date: June 29, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure		Assessed 24 times over four hours
Secondary	Agreement between the T-line and right heart catheter in determining cardiac output		Assessed every 30 minutes over four hours