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

NCT01311128 | Terminated DMC

• 1 other identifier: 6980
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Assessed 24 times over four hours

Secondary Outcomes (1)

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

  Assessed every 30 minutes over four hours

Study Arms (1)

Heart rate and blood pressure determination

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

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

Interventions

T-line hemodynamic monitoring device (placement and use) DEVICE

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.

Also known as: T-line, Tensymeter, Tensys Medical, Inc., Hemodynamic monitoring

Heart rate and blood pressure determination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Critical Illness

Interventions

Mutagenesis, Insertional; Hemodynamic Monitoring

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Charles Phillips, MD

  503-494-2465

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 9, 2011
• Study Start: February 16, 2011
• Primary Completion: June 29, 2012
• Study Completion: December 30, 2014
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)