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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04155892
Enrollment
760
Registered
2019-11-07
Start date
2019-12-04
Completion date
2025-07-03
Last updated
2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Tract Infections

Keywords

Extubation criteria, Pediatric Anesthesia, Outpatient surgery

Brief summary

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

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.

Interventions

None listed

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Rate of participants with a successful extubationDay 1The quality of extubation will be graded as successful, intervention required or major intervention required
The rate of successful extubation in children with at least 3 of the five criteria presentDay 1The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume \> 5 cc/kg)
Rate of participants with an extubation requiring interventionDay 1The quality of extubation will be graded as successful, intervention required or major intervention required
Rate of participants with an extubation requiring major interventionDay 1The quality of extubation will be graded as successful, intervention required or major intervention required

Secondary

MeasureTime frameDescription
Rate of on time and anticipated discharge from the hospitalUp to 5 days after discharge
Rate of patients seeking additional care following discharge for respiratory related symptomsUp to 5 days after discharge
Preoperative room air oxygen saturationDay 1
Rate of extubation success per the number of factors present at time of extubationDay 1Rate 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026