NCT07868978

Brief Summary

This single-centre prospective study measured the internal diameter of the radial artery and the distance between the skin surface and the arterial lumen by ultrasound in 76 adults with a body mass index of 40 kg/m2 or above who were scheduled for elective surgery under general anaesthesia. Measurements were made 2 cm proximal to the radial styloid process before induction of anaesthesia and again 5 minutes after endotracheal intubation, so that each patient served as their own control. The relationship of these measurements with anthropometric variables was examined. Patients were additionally randomized to radial artery cannulation with either an 18 G or a 20 G cannula, and the two cannula gauges were compared with respect to the time to successful cannulation and the number of skin punctures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
Last Updated

October 9, 2026

Status Verified

October 1, 2026

Enrollment Period

4 months

First QC Date

September 30, 2026

Last Update Submit

October 8, 2026

Conditions

Keywords

radial artery; ultrasonography, interventional; anaesthesia, general; arterial cannulation; body mass index

Outcome Measures

Primary Outcomes (1)

  • Change in internal diameter of the radial artery

    Internal diameter of the radial artery measured by ultrasound in the long-axis view, 2 cm proximal to the radial styloid process, with the wrist in 45 degrees of extension. The outcome is the within-patient difference between the measurement before induction of anaesthesia and the measurement after intubation.

    Before induction of anaesthesia and 5 minutes after endotracheal intubation

Secondary Outcomes (4)

  • Distance between the skin surface and the radial artery lumen

    Before induction of anaesthesia and 5 minutes after endotracheal intubation

  • Relationship between arterial dimensions and anthropometric variables

    At the time of the through study completion, an average of 4 months

  • Time to successful cannulation

    During radial artery cannulation, immediately after the second ultrasound measurement

  • Number of skin punctures required for successful cannulation

    During radial artery cannulation, immediately after the second ultrasound measurement

Study Arms (2)

20 G cannula

ACTIVE COMPARATOR

Radial artery cannulation with a 20 G arterial cannula (outer diameter 1.1 mm, length 32 mm) after the second ultrasound measurement. n = 38

Device: 20 G arterial cannulaDevice: 18 G arterial cannula

18 G cannula

ACTIVE COMPARATOR

Radial artery cannulation with an 18 G arterial cannula (outer diameter 1.3 mm, length 45 mm) after the second ultrasound measurement. n = 38.

Device: 20 G arterial cannulaDevice: 18 G arterial cannula

Interventions

Ultrasound-guided radial artery cannulation using a 20 G arterial cannula. The probe was placed in the short axis to identify the artery and cannulation was performed in the long axis

18 G cannula20 G cannula

Ultrasound-guided radial artery cannulation using an 18 G arterial cannula, by the same technique.

18 G cannula20 G cannula

Eligibility Criteria

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

You may qualify if:

  • Age 18 to 60 years
  • Body mass index 40 kg/m2 or above
  • American Society of Anesthesiologists physical status III
  • Scheduled for elective surgery under general anaesthesia

You may not qualify if:

  • Refusal to participate
  • Haemodynamic instability
  • Coronary artery disease
  • Peripheral artery disease
  • Diabetes mellitus
  • Hypertension
  • Known radial or ulnar vascular pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Department of Anaesthesiology and Reanimation Cerrahpaşa Faculty of Medicine, Istanbul University

    Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaş

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Observational paired measurement of radial artery dimensions before and after induction of general anaesthesia, with participants randomised to one of two cannula gauges for the subsequent arterial cannulation.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Department of Anaesthesiology and Reanimation, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa

Study Record Dates

First Submitted

September 30, 2026

First Posted

October 9, 2026

Study Start

November 5, 2020

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

October 9, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Individual participant data are not available. The study was conducted as a medical specialty thesis and only aggregate data were retained.

Locations