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

Sedation Clinical Trial

Official title:

The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01957566
• Other study ID #: HSC 2012-0259
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: March 22, 2017

Study information

• Verified date: December 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 22, 2017
• Est. primary completion date: March 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Sedation

Intervention

Procedure:
• APS

Locations

Country	Name	City	State
United States	American Family Children's Hospital (AFCH)	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	A stridor score of less than 2 will be defined as not sedation-related event.		Day 1 of sedation.
Secondary	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.	Day 1 of propofol sedation.