PRAE and Asymptomatic and Symptomatic URI Patients

Incidence of PRAE on Asymptomatic and Symptomatic URI Surgical Patients

The objective of this study is to determine the prevalence of asymptomatic viral carriers among healthy surgical patients and to describe the demographic and clinical characteristics of these patients. The secondary objective is to compare the incidence of perioperative respiratory adverse events (PRAE) between virus positive patients with and without upper respiratory infection (URI) symptoms. The secondary objective would aim to enroll patients who report recent URI symptoms.

Study Overview

• Status: Not yet recruiting
• Conditions: Upper Respiratory Infection; Perioperative Respiratory Adverse Events; Pediatric Surgical Patients
• Intervention / Treatment: Diagnostic test: Mid-turbinate nasal swab

Detailed Description

The primary endpoint is to determine the prevalence of asymptomatic viral carriers among healthy pediatric surgical patients and describe the demographic and clinical characteristics of these patients. This will be done using prospectively collected respiratory swabs from healthy asymptomatic children undergoing elective pediatric surgery. This will result in a quantifiably proportion of children who test positive for respiratory viruses. This aim will define the epidemiologic baseline of silent viral URIs in children undergoing elective surgery. We can then evaluate the association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs). A secondary endpoint will be to compare the incidence of PRAE between virus positive patients with and without URI symptoms. This will be done by prospectively enrolling patients who report recent (within 2 weeks) or current URI symptoms.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Catherine Roth; Phone Number: 614-722-2997; Email: catherine.roth@nationwidechildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients <18 presenting at NCH for elective ambulatory procedures under general anesthesia.

100 patients who are asymptomatic for URI symptoms 200 patients who report recent (within 2 weeks) or current URI symptoms.

Description

Inclusion Criteria:

• Patients <18 years of age presenting for elective ambulatory procedures under general anesthesia at NCH. Patient will either identify as asymptomatic or have had URI symptoms currently or within the past two weeks.

Exclusion Criteria:

• Chronic medical problems (excluding asthma), diagnosis of cancer, transplant recipient, receiving immunomodulatory medications (cyclosporine, tacrolimus, azathioprine, mycophenolate, monoclonal AB, lithium), or currently prescribed antibiotics.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Recent URI patients; Pediatric patients who report recent (within two weeks) or current URI symptoms presenting for surgery	Diagnostic test: Mid-turbinate nasal swab; Mid-turbinate nasal swab for viral testing using a PCR film array test (qRT-PCR).
Healthy pediatric patients; Healthy pediatric patients without respiratory symptoms scheduled for surgery	Diagnostic test: Mid-turbinate nasal swab; Mid-turbinate nasal swab for viral testing using a PCR film array test (qRT-PCR).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.	All patients will be tested for the presence of viruses that cause upper respiratory infections by taking a mid-turbinate nasal swab and using a PCR film array test.	From enrollment to the end of the surgery, no more than 8 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs).	Occurrence of PRAE during or after surgery.	Time of enrollment to time of hospital discharge, no more than 24 hours.

Collaborators and Investigators

• Sponsor: Brittany Willer
• Investigators: Principal Investigator: Brittany Willer, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: September 8, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 14, 2026

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: PRAE; Asymptomatic URI; Symptomatic URI
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: STUDY00005442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No