Patient Experience in Peripheral Venipuncture With and Without Ultrasound

NCT04853290 | Completed

• 1 other identifier: 40240920.6.0000.5327
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial to compare the patient's experience after 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; Pain

Keywords

Peripheral venous catheterization; Ultrasonography; Pain; Patient satisfaction; Nursing; Clinical trial

Outcome Measures

Primary Outcomes (3)

• Patient's experience of pain during the procedure

  Patient's experience of pain during the procedure of peripheral venipuncture, evaluated immediately after the procedure using the 10 cm verbal Numerical Rating Scale (vNRS). The response indicated by the patient regarding the degree of felt pain during the procedure, from 0 to 10, with 10 being the most intense pain, will be computed.

  up to 5 minutes.

• Patient's experience with the method used to obtain venous access (1/2)

  Patient's experience with the method used to obtain venous access, assessed using the Net Promoter Score (NPS), a single metric instrument that quantifies the answers to a single direct research question: "How likely are you to recommend this procedure?". Three categories of respondents are identified and classified as 'promoters' (those who would definitely recommend), 'passive' (who are widely satisfied, but would not recommend) and 'detractors' (who actively discourage others from trying the procedure).

  up to 5 minutes.

• Patient's experience with the method used to obtain venous access (2/2)

  Additionally, it will be assessed the elements: a) patient emotional aspect during the procedure (anxiety, discomfort, importance of the procedure, fear, concern, safety); b) venous catheter insertion site; c) number of venipuncture attempts; d) dressing and device fixation on the skin; e) procedure's time duration; as relevant indicators for the characterization of the procedure as a positive or a negative experience for the patients. Data will be computed using a 10 point Likert scale score, in which 1 point rates the worst experience and 10 points an excellent experience.

  up to 10 minutes.

Secondary Outcomes (2)

• Peripheral intravenous catheter dwell time

  Daily monitoring, until catheter removal

• Complications during the vascular access device permanence

  Daily monitoring, up 2 days after catheter removal

Study Arms (2)

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 from a clinical inpatient unit.

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.

Intervention group

Conventional peripheral venipuncture DEVICE

Conventional peripheral venipuncture performed by the registered nurse at the clinical inpatient unit. The procedure will be performed according to the standard operational protocol for peripheral venipuncture protocol 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;
• Admitted to the clinical inpatient units on 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

Related Publications (1)

• Tada M, Yamada N, Matsumoto T, Takeda C, Furukawa TA, Watanabe N. Ultrasound guidance versus landmark method for peripheral venous cannulation in adults. Cochrane Database Syst Rev. 2022 Dec 12;12(12):CD013434. doi: 10.1002/14651858.CD013434.pub2.

  PMID: 36507736 DERIVED

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

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 is a PROBE (Prospective Randomized Open Blinded End Point), parallel, controlled, and single center randomized clinical trial (RCT).

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: September 23, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)