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

NCT ID: NCT04155892

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-04

Study Completion Date

2025-07-03

Brief Summary

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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

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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.

Conditions

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Upper Respiratory Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

non-URI group

This group includes participants \<8 years of age undergoing elective procedures with no URI symptoms or recent URI.

No interventions assigned to this group

Eligibility Criteria

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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).
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Templeton, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00056059

Identifier Type: -

Identifier Source: org_study_id

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