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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-03-22

Brief Summary

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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

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Conditions

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Sedation

Keywords

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propofol sedation children procedure sedation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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APS

Group Type EXPERIMENTAL

APS

Intervention Type PROCEDURE

Interventions

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APS

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juan Boriosi, MD

Role: PRINCIPAL_INVESTIGATOR

UW Madison

Locations

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American Family Children's Hospital (AFCH)

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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HSC 2012-0259

Identifier Type: -

Identifier Source: org_study_id