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

Terminated

• Conditions: Critically Ill
• Interventions: Device: T-line hemodynamic monitoring device (placement and use)

• Registration Number: NCT01311128
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-16
• Study First Submitted: 2011-03-08
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-09
• Primary Completion: 2012-06-29
• Study Completion: 2014-12-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart rate and blood pressure determination	T-line hemodynamic monitoring device (placement and use)	All subjects have the same conditions (T-line, blood pressure cuff, and radial artery catheter), in order to compare them within-subjects.

Primary Outcome Measures

Name	Time	Method
Agreement between radial catheter, blood pressure cuff, and T-line in determining heart rate and blood pressure	Assessed 24 times over four hours

Secondary Outcome Measures

Name	Time	Method
Agreement between the T-line and right heart catheter in determining cardiac output	Assessed every 30 minutes over four hours

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States