The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children

Not Applicable

Completed

• Conditions: Sedation
• Interventions: Procedure: APS

• Registration Number: NCT01957566
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-17
• Study First Submitted QC: 2013-09-30
• Study First Posted: 2013-10-08
• Study Start: 2015-02
• Primary Completion: 2017-03-22
• Study Completion: 2017-03-22
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
APS	APS	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

American Family Children's Hospital (AFCH); 🇺🇸 Madison, Wisconsin, United States