Prospective Observational Study of Difficult Intravenous Access in the Operating Room

Difficult Intravenous Access Clinical Trial

Official title:

Prospective Observational Study of Difficult Intravenous Access in the Operating Room

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591016
• Other study ID #: IRB18-00495
• Status: Completed
• Start date: July 2, 2018
• Est. completion date: December 8, 2020

Study information

• Verified date: February 2021
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 8, 2020
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Intravenous Access

Intervention

Other:
• Recording number of IV attempts
Recording number of IV attempts in the operating room

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ralph Beltran

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time it takes to insert an IV		between 1 to 30 minutes
Secondary	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
Secondary	Actual difficulty	Provider's assessment of how difficult the actual IV insertion was on the same Likert scale.	between 1 to 30 minutes