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

NCT03642756 | Unknown

• 1 other identifier: catheter size
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheters

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The difference of mean blood pressure between invasive blood pressure and non-invasive blood pressure

  1 minute after cannulation

Study Arms (3)

20 gauge

PLACEBO COMPARATOR

Device: different intra-arterial catheter size

22 gauge

ACTIVE COMPARATOR

Device: different intra-arterial catheter size

24 gauge

ACTIVE COMPARATOR

Device: different intra-arterial catheter size

Interventions

different intra-arterial catheter size DEVICE

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.

20 gauge; 22 gauge; 24 gauge

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33527182 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 22, 2018
• Study Start: October 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 22, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)