PRAE and Asymptomatic and Symptomatic URI Patients

N/ANot Yet RecruitingNCT07816822

Brittany Willer300 enrolled

Overview

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.

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

300

Conditions

Upper Respiratory Infection Pediatric Surgical Patients Perioperative Respiratory Adverse Events

Interventions

Mid-turbinate nasal swabDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 0 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the end of the surgery, no more than 8 hours.

Secondary Outcomes

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

Occurrence of PRAE during or after surgery.

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

Central Contacts

Catherine Roth

CONTACT

614-722-2997 catherine.roth@nationwidechildrens.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.