Back to resultsThe Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
Primary Purpose
Sedation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
APS
Sponsored by
About this trial
This is an interventional screening trial for Sedation focused on measuring propofol sedation, children, procedure sedation
Eligibility Criteria
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
Sites / Locations
- American Family Children's Hospital (AFCH)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APS
Arm Description
Outcomes
Primary Outcome Measures
An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event
A stridor score of less than 2 will be defined as not sedation-related event.
Secondary Outcome Measures
The positive predictive value and negative predictive value of the APS for predicting airway obstruction.
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.
Full Information
NCT ID
NCT01957566
First Posted
January 17, 2013
Last Updated
December 21, 2018
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT01957566
Brief Title
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
Official Title
The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
March 22, 2017 (Actual)
Study Completion Date
March 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sedation
Keywords
propofol sedation, children, procedure sedation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APS
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
APS
Primary Outcome Measure Information:
Title
An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event
Time Frame
Day 1 of propofol sedation.
Title
A stridor score of less than 2 will be defined as not sedation-related event.
Time Frame
Day 1 of sedation.
Secondary Outcome Measure Information:
Title
The positive predictive value and negative predictive value of the APS for predicting airway obstruction.
Description
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.
Time Frame
Day 1 of propofol sedation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Boriosi, MD
Organizational Affiliation
UW Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
American Family Children's Hospital (AFCH)
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
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