Evaluating extubation criteria for children with upper respiratory infections
A Prospective Observational Study Evaluating Extubation Criteria in Children Less Than 8 Years of Age With Upper Respiratory Infection Undergoing Outpatient or Day Hospital Based Surgery
This study is testing if certain guidelines and a questionnaire can help doctors decide when it's safe to take breathing tubes out of children with upper respiratory infections after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 760 (estimated) |
| Ages | N/A to 7 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT04155892 on ClinicalTrials.gov |
What this trial studies
This study aims to optimize preoperative screening for pediatric patients undergoing surgery with upper respiratory infections. It evaluates various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. The study will assess the effectiveness of room air oxygen levels and a preoperative URI questionnaire in predicting outcomes for these patients. Data collection is focused on children who require general anesthesia and endotracheal intubation.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients undergoing elective surgery with an endotracheal tube and a score of at least 3 on a preoperative URI survey.
Not a fit: Patients with a history of home oxygen use, ventilator dependence, or those undergoing emergent procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and outcomes of pediatric surgeries in children with upper respiratory infections.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies evaluating extubation criteria in pediatric patients have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Templeton, MD — Wake Forest University Health Sciences
- Study coordinator: Thomas Templeton, MD
- Email: ttemplet@wakehealth.edu
- Phone: 336-716-4498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.