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Completed

NCT Number: NCT04155892

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

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

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Key information

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. The rate of successful extubation in children with at least 3 of the five criteria present

    Time frame: Day 1

    The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume > 5 cc/kg)

  2. Rate of participants with an extubation requiring intervention

    Time frame: Day 1

    The quality of extubation will be graded as successful, intervention required or major intervention required

  3. Rate of participants with an extubation requiring major intervention

    Time frame: Day 1

    The quality of extubation will be graded as successful, intervention required or major intervention required

  4. Rate of participants with a successful extubation

    Time frame: Day 1

    The quality of extubation will be graded as successful, intervention required or major intervention required

Secondary outcomes

  1. Rate of on time and anticipated discharge from the hospital

    Time frame: Up to 5 days after discharge

  2. Rate of patients seeking additional care following discharge for respiratory related symptoms

    Time frame: Up to 5 days after discharge

  3. Preoperative room air oxygen saturation

    Time frame: Day 1

  4. Rate of extubation success per the number of factors present at time of extubation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 7, 2019
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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