NCT03995264

Brief Summary

The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2.4 years

First QC Date

June 20, 2019

Last Update Submit

January 7, 2022

Conditions

Obese

Outcome Measures

Primary Outcomes (1)

  • Success rate

    Success rate at first attempt for radial artery cannulation

    at first attempt, as average 5 min

Study Arms (2)

Ultrasound group

EXPERIMENTAL

Ultrasound-guided radial artery cannulation

Procedure: Ultrasound -guided cannulation

Palpation group

PLACEBO COMPARATOR

Radial artery cannulation with palpation technique

Procedure: Palpation -guided cannulation

Interventions

Ultrasound -guided cannulationPROCEDURE

radial artery cannulation using the ultrasound

Ultrasound group
Palpation -guided cannulationPROCEDURE

radial artery cannulation using the palpation

Palpation group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists 1, 2, 3 BMI ≥ 30 bariatic surgery

You may not qualify if:

  • refusal infection or surgery history in wrist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine

Suwon, Seoul, South Korea

Location

Related Publications (1)

  • Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.

    PMID: 34637140DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 20, 2019

First Posted

June 24, 2019

Study Start

August 1, 2019

Primary Completion

January 7, 2022

Study Completion

January 7, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

KR(1)