PRAE and Asymptomatic and Symptomatic URI Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-18
SponsorBrittany Willer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Mid-turbinate nasal swab

    Diagnostic test

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

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Recent URI patients1 intervention
Group B: Healthy pediatric patients1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brittany Willer

Lead sponsor

Nationwide Children's Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: