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

Catheters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03642756
• Other study ID #: catheter size
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 366
• Est. completion date: December 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheters

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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