SedationNCT01957566
The Utility of Pretracheal Stethoscope in Detecting Respiratory Abnormalities in Sedated Children
A study testing APS in people with Sedation, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Sedation
- What is being tested?
- APS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 22 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
American Family Children's Hospital (AFCH)
Madison, Wisconsin, 53792
About this study
Official title: The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study
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.
- Conditions
- Sedation
- Being tested
- APS
- Keywords
- propofol sedation, children, procedure sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APSProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| APS | Experimental | Not described Receives: Procedure: APS |
What is being measured
The primary outcome is the main question the study is designed to answer.
An auscultation of a stridor score greater than or equal to 2 will be defined as a sedation-related adverse acute respiratory event
Measured: Day 1 of propofol sedation.
A stridor score of less than 2 will be defined as not sedation-related event.
Measured: Day 1 of sedation.
Secondary outcomes (1)
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.
Measured: Day 1 of propofol sedation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startFeb 2015
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Boriosi, MD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957566
- Sponsor's protocol ID
- HSC 2012-0259
- Status last verified
- Dec 2018
- First submitted
- 17 Jan 2013
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Amplified Pretracheal Stethoscope in Detecting Ventilatory Abnormalities During Propofol Sedation of Non Intubated Children: a Validation Study
- ClinicalTrials.gov ID
- NCT01957566
- Acronym / sponsor ID
- HSC 2012-0259
- Conditions
- Sedation
- Keywords
- propofol sedation, children, procedure sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APS | Experimental | Procedure: APS |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- ASA scoring > 3
- Oxygen requirement and cardiorespiratory instability
- Allergy to propofol or its components
- Patients requiring propofol sedation outside the AFCH Pediatric Sedation Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APS | Procedure or surgery | APS |
Primary outcome
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.
A stridor score of less than 2 will be defined as not sedation-related event.
Time frame: Day 1 of sedation.
1 secondary outcome
The positive predictive value and negative predictive value of the APS for predicting airway obstruction.
Time frame: Day 1 of propofol sedation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Boriosi, MD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APS in people with Sedation, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.