Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

Healthy Clinical Trial

Official title:

Noninvasive Blood Pressure Monitor Evaluation Including Performance During Dysrhythmias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443001
• Other study ID #: CS 347
• Status: Completed
• Phase: N/A
• Start date: April 2007
• Est. completion date: July 2007

Study information

• Verified date: July 2022
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Healthy

Intervention

Device:
• Non invasive blood pressure monitor
Updated device and software to improve performance in patients with dysrhythmia

Locations

Country	Name	City	State
United States	GE Healthcare	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1-4 hours