Ultrasound Guided Peripheral IV Insertion

Anesthesia Clinical Trial

— USGPIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841864
• Other study ID #: Pro00054941
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: May 13, 2022

Study information

• Verified date: May 2022
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: May 13, 2022
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Other:
• IV placement using ultrasound guidance vs traditional method
Ultrasound guided IV placement

Locations

Country	Name	City	State
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Grade 2B and Grade 3 vein classification IV placement success rate	Ultrasound IV insertion success rate for grade 2B and grade 3 using ultrasound	9 months after patient recruitment begins