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

NCT04155892 | Completed

• 1 other identifier: IRB00056059
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 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.

Conditions

Upper Respiratory Tract Infections

Keywords

Extubation criteria; Pediatric Anesthesia; Outpatient surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

  Day 1

Study Arms (2)

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.

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Thomas Templeton, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: November 7, 2019
• Study Start: December 4, 2019
• Primary Completion: June 30, 2025
• Study Completion: July 3, 2025
• Last Updated: January 16, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)