Prospective Observational Study of Difficult Intravenous... | NCT03591016

Studies
Prospective Observational Study of Difficult Intravenous Access in the Operating Room

NCT03591016

Sponsor

Ralph Beltran

Status

Completed

Last Update Posted

Feb 15, 2021Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Difficult Intravenous Access

Interventions

Recording number of IV attempts

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2018Actual

Primary Completion Date

Dec 8, 2020Actual

Completion Date

Dec 8, 2020Actual

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Jul 17, 2018

First Posted Date

Jul 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2021

Last Update Posted Date

Feb 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Difficult intravenous access		Recording number of IV attempts in the operating room prior to surgery start.	Other: Recording number of IV attempts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recording number of IV attempts	Other	Recording number of IV attempts in the operating room	Difficult intravenous access

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ralph Beltran, MD	Nationwide Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States