NCT03405428

Brief Summary

In this study, the investigators will investigate how patients' radial artery diameters change according to sex, age, height, weight and body mass index by measuring radial artery diameter using ultrasonography. The correlation of Allen test with doppler ultrasonography will also be evaluated.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

January 4, 2018

Last Update Submit

March 12, 2018

Conditions

AnesthesiaUltrasonographyRadial ArteryCatheterization

Keywords

UltrasonographyRadial Artery DiameterAllen TestArterial CannulationDoppler UltrasonographyUlnar Artery

Outcome Measures

Primary Outcomes (1)

  • change of the radial artery diameter according to sex, age, height, weight and body mass index

    Ultrasonography measurements will be performed with a linear probe. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degree with a wrist pad. The Ultrasonography probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.

    5 minutes prior to anesthesia induction

Secondary Outcomes (2)

  • correlation between Allen test and doppler ultrasonography.

    5 minutes prior to anesthesia induction

  • change of the radial artery diameter according to sex, age, height, weight and body mass index after the induction

    5 minutes following to anesthesia induction

Study Arms (1)

All patients

OTHER
Other: Allen testOther: Radial artery diameter measurement by ultrasonographyOther: Ulnar artery doppler ultrasonography

Interventions

Allen testOTHER

Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several times until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. Overextension of the hand and wide spreading of the fingers should be avoided because it can lead to falsely abnormal results. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds.

All patients
Radial artery diameter measurement by ultrasonographyOTHER

Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.

All patients
Ulnar artery doppler ultrasonographyOTHER

Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar arter will be scanned. The blood fow of ulnar artery will be measured and recorded.

All patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients will be operated under general anesthesia
  • patients were American Society of Anesthesiology (ASA) physical status I or II

You may not qualify if:

  • ASA III, IV, V
  • History of coroner artery disease
  • History of peripheral artery disease,
  • History of diabetes mellitus,
  • History of hypertension
  • Hemodynamic instability
  • Hypovolemia
  • History of Reynaud phenomenon
  • History of hand or arm trauma
  • previous catheterization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • Güniz Meyancı Köksal, Prof.

    Istanbul University Cerrahpasa Medical Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşe Sıla Akkuş

CONTACT

00905553044975aysesilaakkus@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 23, 2018

Study Start

February 1, 2018

Primary Completion

April 1, 2018

Study Completion

April 30, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

TU(1)