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OpenTrials
Completed

NCT Number: NCT01485120

Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinimark

Louisville, Colorado, 80027, United States

About this study

Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written informed consent or have a legally authorized representative provide written informed consent
  • Any volunteer subjects ≥ 18 years of age
  • Subject must have the presence of normal sinus rhythm on ECG
  • Subject will return for follow-up visit from 5 days to 8 days after study procedure

Exclusion criteria

  • Any subject who is unable to provide written informed consent
  • Any subject with the presence of peripheral vascular disease in either arm
  • Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
  • Any subject who cannot tolerate 21 repeated BP measurements
  • Any subjects with clotting or bleeding disorders
  • Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
  • Any subject who is unable to have arterial line placed in the radial artery
  • Any subject that cannot tolerate 4 fast flushes for the frequency response
  • Any female subjects pregnant or lactating
  • Any subject that has previously participated in this study
  • Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit

Treatment and study plan

BP monitoring using two methods

Device

BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.

Primary outcomes

  1. Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading

    Time frame: Approximately 2 hours

    NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).

  2. Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading

    Time frame: Approximately 2 hours

    NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 5, 2011
Registry last updated
May 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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