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

Recruiting

• Conditions: Upper Respiratory Tract Infections

• Registration Number: NCT04155892
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2019-12-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 760

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of participants with a successful extubation	Day 1	The 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 present	Day 1	The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume \> 5 cc/kg)
Rate of participants with an extubation requiring intervention	Day 1	The quality of extubation will be graded as successful, intervention required or major intervention required
Rate of participants with an extubation requiring major intervention	Day 1	The quality of extubation will be graded as successful, intervention required or major intervention required

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States