Clinical trial NCT04853264: Ultrasound Guided Peripheral Catheterization Increases First-attempt Success Rate
Official title: ultraSound Guided PEripheral Catheterization Increases First-atTempt Success RAte in Hospitalized Patients When Compared With Conventional Technique: SPECTRA - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Venous Catheterization
Ultrasonography
Keywords: Peripheral venous catheterization
Ultrasonography
Nursing
Clinical trial
Randomized clinical trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of venipuncture attempts
timeFrame: Immediately after the procedure.
Secondary outcomes:
measure: Time to obtain peripheral venous access
timeFrame: During the procedure
measure: Classification of peripheral venous system conditions
timeFrame: Right before the procedure
measure: Peripheral venous catheters characteristics
timeFrame: Before the procedure.
measure: Vascular and device complications
timeFrame: Up to 8 days.
measure: Venipuncture durability without complications
timeFrame: Up to 8 days.
measure: Infusional therapy characteristics and venipuncture durability
timeFrame: Up to 8 days.
measure: Costs related to the venipuncture techniques used
timeFrame: Up to 8 days.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal do Rio Grande do Sul - Post Graduated Program
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Eneida R Rabelo-Silva, RN, MSc, ScD
role: PRINCIPAL_INVESTIGATOR
References: