Sedation
Conditions
Keywords
propofol sedation, children, procedure sedation
Brief summary
The purpose of the study is to validate the diagnostic performance of the amplified pretracheal stethoscope (APS) to detect sedation-related adverse acute respiratory events in propofol sedated nonintubated children. To determine the sensitivity/specificity and positive/negative predictive value of the APS in detecting sedation-related adverse acute respiratory events in propofol sedated nonintubated children.
Interventions
PROCEDUREAPS
Sponsors
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients 2 years to 18 years of age undergoing induction and maintenance of propofol sedation at the American Family Children's Hospital (AFCH) Pediatric Sedation Clinic * American Society of Anesthesiology score (ASA) of 1-2
Exclusion criteria
* ASA scoring \> 3 * Oxygen requirement and cardiorespiratory instability * Allergy to propofol or its components * Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event | Day 1 of propofol sedation. |
| A stridor score of less than 2 will be defined as not sedation-related event. | Day 1 of sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The positive predictive value and negative predictive value of the APS for predicting airway obstruction. | Day 1 of propofol sedation. | A subject will be considered as evaluable for the sensitivity/specificity evaluation if (1) all inclusion criteria are met, (2) presedation phase is completed, and (3) the sedation induction and maintenance phase is completed. |
Countries
United States
Outcome results
None listed