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

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ClinicalTrials.gov Identifier: NCT04155892
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date November 5, 2019
First Posted Date November 7, 2019
Last Update Posted Date October 27, 2020
Actual Study Start Date December 4, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2019)
  • 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)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 5, 2019)
  • Rate of on time and anticipated discharge from the hospital [ Time Frame: Up to 5 days after discharge ]
  • Rate of patients seeking additional care following discharge for respiratory related symptoms [ Time Frame: Up to 5 days after discharge ]
  • Preoperative room air oxygen saturation [ Time Frame: Day 1 ]
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Upper Respiratory Tract Infections
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 5, 2019)
760
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages up to 7 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Thomas Templeton, MD 336-716-4498 ttemplet@wakehealth.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04155892
Other Study ID Numbers IRB00056059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wake Forest University Health Sciences
Study Sponsor Wake Forest University Health Sciences
Collaborators Not Provided
Investigators
Principal Investigator: Thomas Templeton, MD Wake Forest University Health Sciences
PRS Account Wake Forest University Health Sciences
Verification Date October 2020