Comparison of the Modified and Conventional Approach of Radial Artery Cannulation Under Short-axis Ultrasound Guidance in ICU Hypotensive Patients.

NCT04806932 | Unknown DMC

• 1 other identifier: MARS
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Radial artery cannulation can be performed under short-axis ultrasound guidance. However, the first puncture success rate was low in patients with hypotensive patients. Compared with the conventional approach, the modified approach combined the ultrasonic location system with a dynamic needle tip positioning technique. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided radial artery cannulation in hypotensive ICU patients.

Conditions

Radial Artery Catheterization

Keywords

radial artery catheterization, ultrasound, hypotensive, critical ill

Outcome Measures

Primary Outcomes (1)

• First-pass success

  successful catheterization on the first attempt

  approximately 3 minutes

Secondary Outcomes (5)

• Overall success

  within 10 minutes

• The cannulation time

  within 10 minutes

• Posterior wall puncture

  within 10 minutes

• the number of attempts

  within 10 minutes

• Complication rate

  Day 1

Study Arms (2)

The modified approach

ACTIVE COMPARATOR

The first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed.

Procedure: The modified approach

The conventional approach

PLACEBO COMPARATOR

The first three attempts via the conventional approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed.

Procedure: The conventional approach

Interventions

The modified approach PROCEDURE

The first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed.

The modified approach

The conventional approach PROCEDURE

The conventional approach

The conventional approach

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in intensive care units;
• The need for invasive hemodynamic monitoring (arterial blood pressure and cardiac output monitoring);
• The need for frequent blood sampling (arterial blood gas analysis and general laboratory evaluation);
• Vasopressor therapy;

You may not qualify if:

• a negative Allen test;
• ulnar artery occlusion;
• prevalent atherosclerosis;
• a blocked or embolized target vessel determined by ultrasound assessment;
• Raynaud disease;
• infection near the radial artery puncture site;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Yangpu District Central Hospital Affiliated to Tongji University: collaborator

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

• Quan Z, Tian M, Chi P, Cao Y, Li X, Peng K. Modified short-axis out-of-plane ultrasound versus conventional long-axis in-plane ultrasound to guide radial artery cannulation: a randomized controlled trial. Anesth Analg. 2014 Jul;119(1):163-169. doi: 10.1213/ANE.0000000000000242.

  PMID: 24806143 BACKGROUND

• Liu L, Tan Y, Li S, Tian J. "Modified Dynamic Needle Tip Positioning" Short-Axis, Out-of-Plane, Ultrasound-Guided Radial Artery Cannulation in Neonates: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):178-183. doi: 10.1213/ANE.0000000000003445.

  PMID: 29787409 BACKGROUND

• Clemmesen L, Knudsen L, Sloth E, Bendtsen T. Dynamic needle tip positioning - ultrasound guidance for peripheral vascular access. A randomized, controlled and blinded study in phantoms performed by ultrasound novices. Ultraschall Med. 2012 Dec;33(7):E321-E325. doi: 10.1055/s-0032-1312824. Epub 2012 Oct 11.

  PMID: 23059741 BACKGROUND

Study Officials

• Guowei Tu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongyu He, PhD

CONTACT

021-64041990; he.hongyu@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were randomized to the conventional Approach (CA) or modified Approach (MA) group in a 1:1 ratio using a computerized system. The allocation process was intensively managed by an allocation group using sequentially numbered containers and the allocation result was concealed until it was implemented. When a patient was eligible, the investigator informed the allocation group to get intervention group allocated to the patient: CA orMA group. Because of feasibility issues, operators were not blinded to the assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 19, 2021
• Study Start: April 11, 2021
• Primary Completion: February 1, 2024
• Study Completion: February 28, 2024
• Last Updated: May 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)