Systolic Blood Pressure Measurement in Critically-ill Patients

NCT02366507 | Completed

• 1 other identifier: BPD-02
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional devices to measure blood pressure include automatic sphygmomanometer (pressure) cuff systems or manual blood pressures obtained by auscultation (listening with a stethoscope). Both these techniques fail to provide accurate and consistent blood pressure in the hypotensive (low blood pressure) state, which is often encountered in emergency departments and intensive care units. Alternately, invasive arterial pressure measurement is time-intensive, painful, expensive, and risks include bleeding, infection, and neurovascular injury. In clinical practice, the Doppler velocimetry system is occasionally used in hypotensive, critically-ill patients when an immediate systolic blood pressure measurement is vital for clinical and therapeutic management. With a technique similar to that used to obtain a manual blood pressure, the Doppler velocimetry system can be used in place of the auscultation of the brachial pulse to accurately determine the systolic blood pressure. It is currently unknown whether additional information can be obtained by evaluation of the Doppler waveform in healthy vs. critically-ill patients. The goal is this project is to digitally record Doppler waveforms of critically-ill patients in the Emergency Department (ED) via a standard 8MHz (fetal) Doppler probe, correlate the Doppler readings with current blood pressure and heart rate, and determine if waveform shapes and parameters are predictive of hemodynamic compromise.

Conditions

Hypotension; Shock

Keywords

hypotension; doppler; shock

Outcome Measures

Primary Outcomes (1)

• blood pressure measurements collected under standard of care

  blood pressure measurements collected under standard of care (manual or central line) will be used to compare to Doppler wave form readings.

  day 1

Eligibility Criteria

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

Study Population

Adult patients that present to the Emergency Department with hypotension or suspected shock.

You may qualify if:

• Age ≥ 18
• Systolic Blood Pressure \< 90 mmHg
• Normotensive patients with SBP \> or = 90 mmHg with suspected hypoperfusion/shock

You may not qualify if:

• Patients \< 18 years of age
• Pregnant patients

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• University of North Carolina, Charlotte: collaborator

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28210, United States

Location

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• David A Pearson, MD

  Carolinas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: February 19, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2015
• Last Updated: April 28, 2022

Record last verified: 2016-02

Locations

US (1)