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

University of Wisconsin (UW)

Status: Completed

Conditions: Sedation

Treatments: Procedure: APS

Study type: Interventional

Funder types: Other

Identifiers

NCT01957566

HSC 2012-0259

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

105 participants in 1 patient group

APS

Experimental group

Treatment:

Procedure: APS