Effects of Different Intra-arterial Catheter Size on Frequency of Optimal Dynamic Response in Radial Arterial Waveform

Effects of Different Intra-arterial Catheter Size on the Frequency of Optimal Dynamic Response in Radial Arterial Waveform

The aim of this study is to compare the effects of different intra-arterial catheter size on the frequency of optimal dynamic response in radial arterial waveform.

Study Overview

• Status: Unknown
• Conditions: Catheters
• Intervention / Treatment: Device: different intra-arterial catheter size

• Study Type: Interventional
• Enrollment (Anticipated): 366
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who were scheduled for elective neurosurgery under general anesthesia
• patients with age of 20-79 and ASA class I-III
• patients who are needed to establish invasive arterial pressure monitoring

Exclusion Criteria:

• patients who refuted to be involved in the study
• patients with age of <20 or >80
• patients who had both arm saved
• patients who had a previous history of surgery on radial artery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 20 gauge	Device: different intra-arterial catheter size; in placebo group, patients were cannulated with 20 gauge intra-arterial catheter. In experiment groups, patients were cannulated with 22 gauge or 24 gauge intra-arterial catheter.
Active Comparator: 22 gauge	Device: different intra-arterial catheter size; in placebo group, patients were cannulated with 20 gauge intra-arterial catheter. In experiment groups, patients were cannulated with 22 gauge or 24 gauge intra-arterial catheter.
Active Comparator: 24 gauge	Device: different intra-arterial catheter size; in placebo group, patients were cannulated with 20 gauge intra-arterial catheter. In experiment groups, patients were cannulated with 22 gauge or 24 gauge intra-arterial catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The frequency of adequately damped arterial waveform	The accuracy of arterial blood pressure waveform is depedent on damping coefficient (DC) and natural frequency (NF). The extent to which a monitoring system is damped is expressed by the DC, while the frequency of oscillation that a monitoring system resonates at is known as the NF. The NF and DC are required to be within certain rages for accurate blood pressure monitoring, and they can be affected by different arterial catheter size. Adequately damped arterial waveform can be defined as NF and DC being within certain ranges. For example, waveforms with DC of 0.5 at a NF of 15Hz can be regarded as adequately damped arterial waveform. However, if waveforms have DC of 0.1 at a NF of 15Hz, these can be regarded as not having optimal dynamic response. (There is a reference figure explaining these factors in detail in a previous article. Gardner RM: Direct blood pressure measurement--dynamic response requirements. Anesthesiology 1981; 54:227-3)	1 minute after cannulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference of mean blood pressure between invasive blood pressure and non-invasive blood pressure	At 1 minute after cannulating radial artery, we will obtain information about the mean blood pressure measured in both invasive blood pressure and non-invasive blood pressure. Invasive blood pressure will be measured from radial artery cannulation, and non-invasive blood pressure will be measured by blood pressure cuff at Rt. upper arm. Thereafter, the difference of mean blood pressure between two values will be used for data analysis.	1 minute after cannulation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General Publications

• Oh H, Choe SH, Kim YJ, Yoon HK, Lee HC, Park HP. Intraarterial catheter diameter and dynamic response of arterial pressure monitoring system: a randomized controlled trial. J Clin Monit Comput. 2022 Apr;36(2):387-395. doi: 10.1007/s10877-021-00663-7. Epub 2021 Feb 1.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: catheter size

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No