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Search / Trial NCT04155892

Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Nov 5, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Extubation Criteria Pediatric Anesthesia Outpatient Surgery

ClinConnect Summary

This clinical trial is looking at how to better decide when children with upper respiratory infections (URI) can safely stop using a breathing tube after surgery. The study aims to improve the process of screening young patients before they undergo general anesthesia and surgery, especially if they have a URI. Researchers are collecting data to understand the best practices for managing these children during their procedures.

To participate in this study, children must be scheduled for surgery that requires general anesthesia and a breathing tube. They will be grouped into two categories: those with symptoms of a URI and those without any recent URI symptoms. Eligible participants are generally those who are expected to go home the same day or the day after their surgery. It's important to note that children with certain medical conditions, those needing emergency procedures, or those who have used oxygen at home are not eligible for this trial. If your child qualifies, you can expect to be part of a study that aims to improve safety and care for kids undergoing surgery with upper respiratory infections.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • All study participants must be undergoing general anesthesia and surgery with an endotracheal tube
  • The URI group will be participants with a score of at least 3 on our pre-operative URI survey, with planned airway instrumentation with an endotracheal tube (ETT) for their surgical procedure who are to be discharged same day or on postoperative day 1.
  • The non URI group will be participants undergoing elective procedures with no URI symptom or recent URI. Defined as no URI or "allergy" symptom within the past 6 weeks and a score of 1 or less on the URI survey, with planned airway instrumentation with an ETT for their surgical procedure who are to be discharged same day or on postoperative day 1.
  • Exclusion Criteria:
  • History of home oxygen use or ventilator dependence,
  • Patients undergoing emergent procedures.
  • Patients with cyanotic congenital heart disease.
  • Patients receiving a surgical procedure where the duration of post procedure
  • admission is anticipated to be greater or equal to 2 postoperative days.
  • Patients undergoing anesthesia for imaging procedures alone.
  • Patients who are extubated deep intentionally.
  • Patients intended to be managed with supraglottic airway.
  • Patients undergoing total IV anaesthesia (TIVA).

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Winston Salem, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Thomas Templeton, MD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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