Prospective Observational Study of Difficult Intravenous Access in the Operating Room

Sponsor

Ralph Beltran (Other)

Overall Status

Completed

CT.gov ID

NCT03591016

Collaborator

(none)

1,000

Enrollment

Location

29.2

Actual Duration (Months)

34.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Difficult Intravenous Access	Other: Recording number of IV attempts

Study Design

Study Type:

Observational

Actual Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Observational Study of Difficult Intravenous Access in the Operating Room

Actual Study Start Date :

Jul 2, 2018

Actual Primary Completion Date :

Dec 8, 2020

Actual Study Completion Date :

Dec 8, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Time it takes to insert an IV [between 1 to 30 minutes]

Secondary Outcome Measures

Anticipated difficulty [Baseline]
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.
Actual difficulty [between 1 to 30 minutes]
Provider's assessment of how difficult the actual IV insertion was on the same Likert scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

Ralph Beltran

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ralph Beltran, Staff Anesthesiologist, Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT03591016

Other Study ID Numbers:

IRB18-00495

First Posted:

Jul 18, 2018

Last Update Posted:

Feb 15, 2021

Last Verified:

Feb 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Feb 15, 2021