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OpenTrials
Completed

NCT Number: NCT00443001

Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

This protocol focuses on the evaluation of the GE noninvasive blood pressure parameter in subjects with dysrhythmias and normal sinus rhythm. The study follows the recommendations of the ANSI/AAMI SP10 Standard.

Completed

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GE Healthcare

Milwaukee, Wisconsin, 53223, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • signed informed consent
  • a patient who is undergoing a specialized procedure such as a surgical procedure or cardiac catheterization, or during critical care monitoring in which a central arterial catheter is in place to determine systolic, diastolic, and/or mean arterial blood pressure values.
  • ability to monitor ECG, NIBP and/or pulse oximetry
  • presence of atrial fibrillation, atrial flutter, or normal sinus rhythm

Exclusion criteria

  • any subject deemed too unstable, at the clinician's discretion, to participate in the study
  • any subject with a cardiac or vascular malformation that results in an abnormal waveform inappropriate to be considered a reference standard
  • any subject with a cardiac anomaly that would cause a disparity between aortic pressures and the periphery.
  • presence of peripheral vascular disease in arms
  • inability to perform a minimum of 4 fast flushes (two at the study beginning and two at the study end) on an arterial catheter or line in order to determine a frequency response. The volume of fluid will not exceed a total pre-specified by the Principal Investigator or designee.
  • if the baseline arm to arm mean difference is > 10 mmHg, then the differences will be recorded and evaluated by the Principal Investigator for possible subject exclusion from the data analysis.
  • subjects who, at the clinician's discretion, could not tolerate approximately 5 to 12, but possibly up to 25 repeated blood pressures on each arm

Treatment and study plan

Non invasive blood pressure monitor

Device

Updated device and software to improve performance in patients with dysrhythmia

Primary outcomes

  1. Comparison of early systolic, systolic, and diastolic blood pressure, MAP and pulse rate as collected by an investigational non-invasive blood pressure device versus reference standards

    Time frame: 1-4 hours

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 5, 2007
Registry last updated
Jul 27, 2022

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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