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Completed

NCT Number: NCT01957566

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

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.

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Key information

Conditions

Sedation

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

American Family Children's Hospital (AFCH)

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APS

Procedure

Primary outcomes

  1. 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.

  2. A stridor score of less than 2 will be defined as not sedation-related event.

    Time frame: Day 1 of sedation.

Secondary outcomes

  1. The positive predictive value and negative predictive value of the APS for predicting airway obstruction.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 8, 2013
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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