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

Upper Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04155892
• Other study ID #: IRB00056059
• Status: Recruiting
• Start date: December 4, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Wake Forest University Health Sciences
• Contact: Thomas Templeton, MD
• Phone: 336-716-4498
• Email: ttemplet[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 760
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful extubation in children with at least 3 of the five criteria present	The 5 criteria (facial grimace, eye opening, conjugate gaze, purposeful movement, and tidal volume > 5 cc/kg)	Day 1
Primary	Rate of participants with an extubation requiring intervention	The quality of extubation will be graded as successful, intervention required or major intervention required	Day 1
Primary	Rate of participants with an extubation requiring major intervention	The quality of extubation will be graded as successful, intervention required or major intervention required	Day 1
Primary	Rate of participants with a successful extubation	The quality of extubation will be graded as successful, intervention required or major intervention required	Day 1
Secondary	Rate of on time and anticipated discharge from the hospital		Up to 5 days after discharge
Secondary	Rate of patients seeking additional care following discharge for respiratory related symptoms		Up to 5 days after discharge
Secondary	Preoperative room air oxygen saturation		Day 1
Secondary	Rate of extubation success per the number of factors present at time of extubation	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	Day 1