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Ultrasound Guided Peripheral IV Insertion

A Comparison of Traditional Technique Peripheral Intravenous [PIV] Catheter Insertion to the Utilization of Ultrasound Guidance for the Development of a Vein Classification System and Difficult IV Insertion Algorithm. A Prospective Observational Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03841864
Acronym
USGPIV
Enrollment
667
Registered
2019-02-15
Start date
2019-01-21
Completion date
2022-05-13
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

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

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

Interventions

OTHERIV placement using ultrasound guidance vs traditional method

Ultrasound guided IV placement

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique9 months after patient recruitment beginsIV insertion success rate comparison on the second IV insertion attempt (after after 1x unsuccessful IV insertion using traditional technique) between traditional technique versus ultrasound guidance for grade 1 and 2a visual vein classification grades. For an 80% powered study to detect a 30% difference in success rate, an N of 50 is required in each group. Outcome will be successful vs unsuccessful IV insertion

Secondary

MeasureTime frameDescription
Grade 2B and Grade 3 vein classification IV placement success rate9 months after patient recruitment beginsUltrasound IV insertion success rate for grade 2B and grade 3 using ultrasound

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026