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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

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.

Condition or disease
Upper Respiratory Tract Infections

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.

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Study Type : Observational
Estimated Enrollment : 760 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155892


Contacts
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Contact: Thomas Templeton, MD 336-716-4498 ttemplet@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Thomas Templeton, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04155892    
Other Study ID Numbers: IRB00056059
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Extubation criteria
Pediatric Anesthesia
Outpatient surgery
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases