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

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

The investigators are currently completing a data collection to try to optimize pediatric patients' preoperative screening, in the setting of an upper respiratory infection.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections

Detailed Description

The objectives of this study are to evaluate various extubation criteria and their predictive value for successful extubation in non-cardiac surgical procedures. To evaluate the predictive value of room air oxygen and an original preoperative URI questionnaire in pediatric patients with URI or URI symptoms.

• Study Type: Observational
• Enrollment (Actual): 760

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

• All study participants must be < 8 years of age and 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 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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
URI group; This group includes participants <8 years of age undergoing elective procedures with a score of at least 3 on our pre-operative URI survey.
non-URI group; This group includes participants <8 years of age undergoing elective procedures with no URI symptoms or recent URI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of successful extubation in children with at least 3 of the five criteria present	The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume > 5 cc/kg)	Day 1
Rate of participants with an extubation requiring intervention	The quality of extubation will be graded as successful, intervention required or major intervention required	Day 1
Rate of participants with an extubation requiring major intervention	The quality of extubation will be graded as successful, intervention required or major intervention required	Day 1
Rate of participants with a successful extubation	The quality of extubation will be graded as successful, intervention required or major intervention required	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of on time and anticipated discharge from the hospital		Up to 5 days after discharge
Rate of patients seeking additional care following discharge for respiratory related symptoms		Up to 5 days after discharge
Preoperative room air oxygen saturation		Day 1
Rate of extubation success per the number of factors present at time of extubation	Rate of success at the presence of 3 to 6 predictors (eye opening, facial grimace, purposeful movement, conjugate gaze, tidal volume > 5 cc/kg, and ETCO2<56 mmHg) at time of extubation	Day 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Thomas Templeton, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): July 3, 2025

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Outpatient surgery; Extubation criteria; Pediatric Anesthesia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: IRB00056059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No