Ultrasound Guided Peripheral Catheterization Increases First-attempt Success Rate

NCT04853264 | Completed

• 1 other identifier: 39802620.0.0000.5327
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial to test the assertiveness on the peripheral vein puncture attempt by comparing two methods: peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture. Patients with indication of peripheral venous puncture, admitted to the clinical inpatient units on the hospital where the study will be conducted (Hospital de Clinicas de Porto Alegre - HCPA) will be enrolled in this single-center trial and will be randomized to conventional peripheral venipuncture performed by a registered nurse; or ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.

Conditions

Peripheral Venous Catheterization; Ultrasonography

Keywords

Peripheral venous catheterization; Ultrasonography; Nursing; Clinical trial; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Number of venipuncture attempts

  Success in the first attempt of venipuncture will be defined by the presence of blood reflux and infusion of 2 mL of saline without complaint of pain or signs of infiltration around the vessel. The number of times the vascular device reaches the skin and subcutaneous tissue with or without rupture of the vessel will be computed.

  Immediately after the procedure.

Secondary Outcomes (7)

• Time to obtain peripheral venous access

  During the procedure

• Classification of peripheral venous system conditions

  Right before the procedure

• Peripheral venous catheters characteristics

  Before the procedure.

• Vascular and device complications

  Up to 8 days.

• Venipuncture durability without complications

  Up to 8 days.

Study Arms (2)

Experimental: intervention group

EXPERIMENTAL

Ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.

Device: Ultrasound-guided peripheral venipuncture

Control group

ACTIVE COMPARATOR

Conventional peripheral venipuncture performed by a registered nurse.

Device: Conventional peripheral venipuncture

Interventions

Ultrasound-guided peripheral venipuncture DEVICE

Ultrasound-guided peripheral venipuncture performed by a proficient vascular access registered nurse. The procedure will be performed according to the standard operational protocol for ultrasound guided peripheral venipuncture instituted at the hospital where the study will be conducted. Site Rite 8 or Site Rite 5 ultrasound machines (Bard Access Systems, Inc., USA) will be used on the procedures.

Experimental: intervention group

Conventional peripheral venipuncture DEVICE

Conventional peripheral venipuncture performed by a registered nurse at the clinical inpatient unit. The procedure will be performed according to the standard operational protocol for peripheral venipuncture instituted in the hospital where the study will be conducted.

Control group

Eligibility Criteria

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

You may qualify if:

• Adults, age = or \> 18 years;
• Both sex;
• Admitted to the clinical inpatient units of the hospital where the study will be conducted (HCPA), with indication of peripheral venous puncture;
• Patients who do not configure emergency care.

You may not qualify if:

• Patients who have already received ultrasound-guided peripheral venipuncture at the current hospitalization;
• Patients in a critical or unstable clinical condition;
• Patients admitted to surgical units at HCPA;
• Patients in coronavirus (COVID-19) care units.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

Study Officials

• Eneida R Rabelo-Silva, RN, MSc, ScD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researchers and investigators responsible for data collection will be blinded for collection and analysis of data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It's a randomized, parallel, controlled, blinded for data collection and analysis, single-center clinical trial; this study will follow the guidelines of the Consolidated Standards of Reporting Trials (CONSORT).

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: September 23, 2021
• Primary Completion: December 30, 2021
• Study Completion: March 31, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: After publication

Locations

BR (1)