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NCT Number: NCT07816822

PRAE and Asymptomatic and Symptomatic URI 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mid-turbinate nasal swab

Diagnostic Test

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

Primary outcomes

  1. Result from mid-turbinate nasal swab to test of viruses that cause URI by qRT-PCR test.

    Time frame: 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 outcomes

  1. Association between asymptomatic viral infections and perioperative respiratory adverse events (PRAEs).

    Time frame: Time of enrollment to time of hospital discharge, no more than 24 hours.

    Occurrence of PRAE during or after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Roth

CONTACT

[email protected]

614-722-2997

Sponsors and collaborators

Lead sponsor

Brittany Willer

Other

Registry information

Official study title

Incidence of PRAE on Asymptomatic and Symptomatic URI Surgical Patients

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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