Clinical trial NCT04155892: Evaluation of Extubation Criteria in Children With Upper Respiratory Infection (URI)
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Upper Respiratory Tract Infections
Keywords: Extubation criteria
Pediatric Anesthesia
Outpatient surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 760
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Primary outcomes:
measure: The rate of successful extubation in children with at least 3 of the five criteria present
timeFrame: Day 1
measure: Rate of participants with an extubation requiring intervention
timeFrame: Day 1
measure: Rate of participants with an extubation requiring major intervention
timeFrame: Day 1
measure: Rate of participants with a successful extubation
timeFrame: Day 1
Secondary outcomes:
measure: Rate of on time and anticipated discharge from the hospital
timeFrame: Up to 5 days after discharge
measure: Rate of patients seeking additional care following discharge for respiratory related symptoms
timeFrame: Up to 5 days after discharge
measure: Preoperative room air oxygen saturation
timeFrame: Day 1
measure: Rate of extubation success per the number of factors present at time of extubation
timeFrame: Day 1
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas Templeton, MD
role: PRINCIPAL_INVESTIGATOR
References: