Preoperative Survey to Evaluate Patient Allergy

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05670756

Collaborator

(none)

1,000

Enrollment

Location

21.1

Anticipated Duration (Months)

47.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.

Condition or Disease	Intervention/Treatment	Phase
Allergy Drug Allergic Reaction Pediatric Surgery	Other: Survey

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Preoperative Survey to Evaluate Patient Allergy List, Type of Response to Listed Medication, and Its Relevance to Perioperative Care

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Medication allergy Patients who have a medication allergy listed in their electronic medical record.	Other: Survey Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.

Arm

Intervention/Treatment

Medication allergy

Patients who have a medication allergy listed in their electronic medical record.

Other: Survey

Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.

Outcome Measures

Primary Outcome Measures

Listed allergies vs actual allergies [Baseline]
The number of allergies listed in the patient's electronic medical record (EMR) compared to actual allergies as described by parent/guardian

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia

Exclusion Criteria:

Patients who are not able cognitively to complete the computerized survey due to physical or intellectual impairment or communication issues related to non-English speaking patients

Contacts and Locations

Locations

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

Sponsors and Collaborators

Nationwide Children's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph D. Tobias, Chief, Dept. of Anesthesiology & Pain Medicine, Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT05670756

Other Study ID Numbers:

STUDY00002974

First Posted:

Jan 4, 2023

Last Update Posted:

Jan 4, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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

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

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Jan 4, 2023