PRAE and Asymptomatic and Symptomatic URI Patients

Incidence of PRAE on Asymptomatic and Symptomatic URI Surgical Patients

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07816822

Enrollment

300

Registered

2026-09-14

Start date

2026-09-01

Completion date

2029-12-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Surgical Patients, Perioperative Respiratory Adverse Events, Upper Respiratory Infection

Keywords

Asymptomatic URI, Symptomatic URI, PRAE

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTMid-turbinate nasal swab

Mid-turbinate nasal swab for viral testing using a PCR film array test (qRT-PCR).

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.	From enrollment to the end of the surgery, no more than 8 hours.	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.

Secondary

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

Contacts

CONTACTCatherine Roth

catherine.roth@nationwidechildrens.org614-722-2997

PRINCIPAL_INVESTIGATORBrittany Willer, MD

Nationwide Children's Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026