Ultrasound Guided Peripheral IV Insertion

NCT ID: NCT03841864

Last Updated: 2022-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

667 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-21

Study Completion Date

2022-05-13

Brief Summary

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Hypothesis The initial use of ultrasound guidance when indicated for difficult peripheral IV access will reduce the number of attempts required to achieve successful peripheral IV insertion and improve patient care and satisfaction.

Detailed Description

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Study objective The purpose of this research study is to compare 2 established peripheral IV insertion techniques (traditional vs ultrasound guided) in order to develop an algorithmic approach to peripheral IV insertion. Patient characteristics, medical history and co-morbidities, in addition to a pre-insertion physical exam vein assessment, will allow for the introduction of a vein classification system and a difficult IV insertion algorithm. Selecting the optimal modality for initial IV insertion will decrease the total number of attempts, facilitate appropriate gauge and location of IV insertion, avoid central line placement, decrease IV insertion pain scores and improve patient satisfaction. Currently, ultrasound guided peripheral IV insertion is performed by the IV team at Cedars-Sinai Medical Center or a trained anesthesia provider as a rescue technique after multiple failed attempts by traditional technique. Secondary to the constraints of both trained providers and equipment resources, the cohort of difficult IV insertion patients are subjected to multiple traditional IV insertion attempts prior to escalation to ultrasound guidance and occasionally, unnecessary central line placements indicated by only poor intravenous access.

Primary end point: Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores, Patient satisfaction Secondary end points: Grade 2B and grade 3 vein classification ultrasound guided IV insertion success rate. Grade 1 and 2a vein classification 1st attempt IV insertion success rate. Grade 1 visualization 2nd attempt IV insertion success rate comparison of traditional vs ultrasound guided technique. Difficult IV insertion risk factors and associations, IV gauge and location, central line placement because of inadequate peripheral IV access

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will partition all CSMC elective pre-operative patients into grade 1, 2a, 2b and 3 classifications to better assess the patient population distribution. Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique, IV insertion pain scores and patient satisfaction, will be compared amongst the 2 different modalities for peripheral IV insertion.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Grade 1 Vein Visualization

Visual vein classification grade described as excellent Visualization. Objective vein criteria to be included in this group are vein raised above skin and wider than 1mm. Initial IV placement will be traditional attempt but subsequent attempts will be provider discretion for traditional vs ultrasound guided placement

Group Type OTHER

IV placement using ultrasound guidance vs traditional method

Intervention Type OTHER

Ultrasound guided IV placement

Grade 2A Vein Visualization

Veins that don't fit grade 1 or 2b classification (see respective group descriptions). This groups visual vein classification is described as fair visualization. Initial IV placement will be traditional attempt but subsequent attempts will be provider discretion for traditional vs ultrasound guided placement

Group Type OTHER

IV placement using ultrasound guidance vs traditional method

Intervention Type OTHER

Ultrasound guided IV placement

Grade 2b Vein Visualization

Only faint vein shadow appearance described as poor visualization. Initial IV placement attempt will be ultrasound guided

Group Type OTHER

IV placement using ultrasound guidance vs traditional method

Intervention Type OTHER

Ultrasound guided IV placement

Grade 3 Vein Visualization

No vein visualization. Initial IV placement attempt will be ultrasound guided

Group Type OTHER

IV placement using ultrasound guidance vs traditional method

Intervention Type OTHER

Ultrasound guided IV placement

Interventions

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IV placement using ultrasound guidance vs traditional method

Ultrasound guided IV placement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All patients requiring pre-operative IV

Exclusion Criteria

* Emergency Surgery, patient refusal, non-english speaking (USGPIV modality available to them but time restrictive to consent for study), pediatrics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Roya Yumul, M.D.,PhD.

Anesthesia Program Director, M.D, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roya Yumul, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36507736 (View on PubMed)

Other Identifiers

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Pro00054941

Identifier Type: -

Identifier Source: org_study_id

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