NCT01957566

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2017

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

2.1 years

First QC Date

January 17, 2013

Last Update Submit

December 21, 2018

Conditions

Sedation

Keywords

propofol sedationchildrenprocedure sedation

Outcome Measures

Primary Outcomes (2)

  • 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.

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

    Day 1 of sedation.

Secondary Outcomes (1)

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

    Day 1 of propofol sedation.

Study Arms (1)

APS

EXPERIMENTAL
Procedure: APS

Interventions

APSPROCEDURE
APS

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • ASA scoring \> 3
  • Oxygen requirement and cardiorespiratory instability
  • Allergy to propofol or its components
  • Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American Family Children's Hospital (AFCH)

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Juan Boriosi, MD

    UW Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

October 8, 2013

Study Start

February 1, 2015

Primary Completion

March 22, 2017

Study Completion

March 22, 2017

Last Updated

December 26, 2018

Record last verified: 2018-12

Locations

US(1)