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Prospective Observational Study of Difficult Intravenous Access in the Operating Room

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591016
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Ralph Beltran, Nationwide Children's Hospital

Study Description
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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
Difficult Intravenous Access Other: Recording number of IV attempts

Study Design
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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 : July 2, 2018
Actual Primary Completion Date : December 8, 2020
Actual Study Completion Date : December 8, 2020
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Time it takes to insert an IV [ Time Frame: between 1 to 30 minutes ]

Secondary Outcome Measures :
  1. Anticipated difficulty [ Time Frame: 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.

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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female 0-18 years old undergoing surgery with anesthesia requiring an IV.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591016


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Ralph Beltran
Investigators
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Principal Investigator: Ralph Beltran, MD Nationwide Children's Hospital
More Information
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Responsible Party: Ralph Beltran, Staff Anesthesiologist, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03591016    
Other Study ID Numbers: IRB18-00495
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No