Ultrasound Guided Peripheral Catheterization Increases First-attempt Success Rate

NCT ID: NCT04853264

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-23
• Study Completion Date: 2022-03-31

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.

Detailed Description

Study Protocol:

When there is a need for peripheral venous access for the inpatient, the medical or nursing care team will contact the researchers, informing the personal data of the possible candidate to participate in the study. By fulfilling the eligibility criteria, the patient will be invited and informed about the study proposal; and, if he agrees to participate, he will sign the consent form. The type of procedure to be performed will be randomized through a draw. The procedure options are:

Intervention: peripheral venipuncture guided by ultrasound by a registered nurse with expertise in vascular access, or Control: conventional peripheral venipuncture by an inpatient care registered nurse.

Individuals who do not agree to participate in the study will have their data stored on a patient exclusion checklist.

In both groups, intervention and control, up to two attempts will be made by the same professional and, if there is no success on the procedure, another professional will be designated for two more attempts. Ultrasound Site Rite 8 or Ultrasound Site Rite 5, which are portable ultrasound devices that include 2D ultrasound imaging in real time, will be used on the Intervention Group (1) procedure.

The peripheral venipuncture procedure for both groups will be performed according to the standard operating procedures recommended by the institution where the study will be conducted (HCPA). The catheters to be used will be the peripheral venous catheters made available by the institution.

If there is a failure of puncture in the Control Group (2), the study participant will follow the institution's routine to adapt an appropriate vascular access, which is the activation of a nurse specialist in vascular access, who can perform peripheral venipuncture guided by ultrasound. In the event of a new insertion failure, the care team (doctor and nurse) discusses the case to define a new approach according to the infusional therapy, considering the protocol for the indication of venous vascular accesses at the institution. Thereafter, the patient can proceed for oral treatment, insertion of a peripherally inserted central catheter, insertion of a short-term central venous catheter, hypodermoclysis, long-term central venous catheter (totally or semi-implanted), according to the decision of the assistant team.

In the case of failure of the puncture in the Intervention Group (1), the study participant will follow the same routine of the institution, as explained above, for the adequacy of an adequate vascular access. However, in this case, the nurse specialist in vascular access will not be contacted, as the intervention procedure already uses ultrasound.

All participants who successfully insert a peripheral venous catheter in both groups will be monitored for the occurrence of any event related to the procedure from the time of insertion of the catheter until the loss of access for any reason, removal of the device at the end of therapy, discharge, death or eight days of follow-up, whichever comes first. Peripheral venous access that remains for more than eight days will be counted as event-free, access survival. Study participants with failed insertion will have the outcome computed in the database and will be followed up for another 48 hours to assess any complications resulting from the puncture attempt.

Conditions

Peripheral Venous Catheterization; Ultrasonography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: intervention group

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

Group Type: EXPERIMENTAL

Ultrasound-guided peripheral venipuncture

Intervention Type: 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.

Control group

Conventional peripheral venipuncture performed by a registered nurse.

Group Type: ACTIVE_COMPARATOR

Conventional peripheral venipuncture

Intervention Type: 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.

Interventions

Ultrasound-guided peripheral venipuncture

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 Type: DEVICE

Conventional peripheral venipuncture

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eneida R Rabelo-Silva, RN, MSc, ScD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

Locations

Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

39802620.0.0000.5327

Identifier Type: -

Identifier Source: org_study_id