Prospective Observational Study of Difficult Intravenous Access in the Operating Room

This is an observational study only, where number of attempts to establish peripheral IV catheter placement will be recorded during procedures in all anesthetizing location on the main campus of Nationwide Children's Hospital.

Study Overview

• Status: Completed
• Conditions: Difficult Intravenous Access
• Intervention / Treatment: Other: Recording number of IV attempts

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.

Description

Inclusion Criteria:

• Patients 0-18 years of age
• Having surgery at Nationwide Children's Hospital

Exclusion Criteria:

• Pre-existing IV upon arrival to the operating room

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Difficult intravenous access; Recording number of IV attempts in the operating room prior to surgery start.	Other: Recording number of IV attempts; Recording number of IV attempts in the operating room

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time it takes to insert an IV	between 1 to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anticipated difficulty	Provider's prediction of how difficult it will be to start the IV on a Likert scale of 1-10, with 10 being the most difficult.	Baseline
Actual difficulty	Provider's assessment of how difficult the actual IV insertion was on the same Likert scale.	between 1 to 30 minutes

Collaborators and Investigators

• Sponsor: Ralph Beltran
• Investigators: Principal Investigator: Ralph Beltran, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2018
• Primary Completion (ACTUAL): December 8, 2020
• Study Completion (ACTUAL): December 8, 2020

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (ACTUAL): July 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IRB18-00495

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No