Columbus, Ohio 43205

  • Difficult Intravenous Access

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

IRB18-00495


NCT ID:

NCT03591016


Secondary ID:


Study Acronym:


Brief Title:

Prospective Observational Study of Difficult Intravenous Access in the Operating Room


Official Title:

Prospective Observational Study of Difficult Intravenous Access in the Operating Room


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Nationwide Children's Hospital


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

1000


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:July 2, 2018
Completion Date:December 8, 2020
Completion Type:Actual
Primary Completion Date:December 8, 2020
Primary Completion Type:Actual
Verification Date:February 2021
Last Changed Date:February 11, 2021
First Received Date:June 20, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Time it takes to insert an IV
Time Frame:between 1 to 30 minutes
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Anticipated difficulty
Time Frame:Baseline
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Actual difficulty
Time Frame:between 1 to 30 minutes
Safety Issues:False
Description:Provider's assessment of how difficult the actual IV insertion was on the same Likert scale.

Study Interventions

Intervention Type:Other
Name:Recording number of IV attempts
Description:Recording number of IV attempts in the operating room
Arm Name:Difficult intravenous access

Study Arms

Study Arm Type:Other
Arm Name:Difficult intravenous access
Description:Recording number of IV attempts in the operating room prior to surgery start.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ralph Beltran

Samples and Retentions

Study Population: Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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