Ultrasound Guided Peripheral IV Insertion

NCT03841864 | Completed DMC

• 1 other identifier: Pro00054941
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Grade 1 and Grade 2A vein classification cohort 2nd IV insertion attempt success rate comparison of traditional vs ultrasound guided technique

  IV 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

  9 months after patient recruitment begins

Secondary Outcomes (1)

• Grade 2B and Grade 3 vein classification IV placement success rate

  9 months after patient recruitment begins

Study Arms (4)

Grade 1 Vein Visualization

OTHER

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

Other: IV placement using ultrasound guidance vs traditional method

Grade 2A Vein Visualization

OTHER

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

Other: IV placement using ultrasound guidance vs traditional method

Grade 2b Vein Visualization

OTHER

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

Other: IV placement using ultrasound guidance vs traditional method

Grade 3 Vein Visualization

OTHER

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

Other: IV placement using ultrasound guidance vs traditional method

Interventions

IV placement using ultrasound guidance vs traditional method OTHER

Ultrasound guided IV placement

Grade 1 Vein Visualization; Grade 2A Vein Visualization; Grade 2b Vein Visualization; Grade 3 Vein Visualization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients requiring pre-operative IV

You may not qualify if:

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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

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

Study Officials

• Roya Yumul, M.D., PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesia Program Director, M.D, PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 15, 2019
• Study Start: January 21, 2019
• Primary Completion: June 30, 2019
• Study Completion: May 13, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)