Pediatric SedationNCT03956342
ClinRO Sedation Validation
An observational study of Pediatric Sedation, run by Duke University at 1 site in United States.
Trial summary
This study will conduct qualitative interviews to provide evidence for the content validity and comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia to facilitate a diagnostic or surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Sedation
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 15 Nov 2019
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be practicing clinicians in a clinical care environment for whom >50% of their patients are sedated/anesthetized for diagnostic and/or therapeutic procedures. Clinicians may be an anesthesiologist, pediatric critical care physician, clinical pharmacist, physician assistant, nurse anesthetist, nurse practitioner, or other nurse with a BSN or higer.
Who may be able to join
- Is a practicing clinician in a clinical care environment
- Cares for pediatric patients >50% of their time
- Treats or works with pediatric patients who are sedated/anesthetized for diagnostic and/or therapeutic procedures
- Holds one of the following titles/positions
- Anesthesiologist
- Pediatric critical care physician
Show all 14Show fewer
- Clinical pharmacist (PharmD)
- Nurse anesthetist
- Nurse practitioner
- Physician assistant
- Nurse (with a BSN/RN or higher)
- Is over the age of 18 years
- Can speak English
- Is capable of giving informed verbal consent
Who cannot join
- 1. Lack of access to a telephone for interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Imperial Building, Duke School of Medicine, Department of Population Health Sciences Office Space
Durham, North Carolina, 27701
About this study
Official title: Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
This study will conduct qualitative interviews to provide evidence for the content validity and comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia to facilitate a diagnostic or surgical procedure. Information gained from this study will inform the use of the measure in studies that are part of the PTN.
Read the detailed description
The primary objective of this study is to assess the content validity and physician understanding of the Pediatric Sedation State Scale (PSSS) and the University of Michigan Sedation Scale (UMSS) via cognitive interviewing methods. Qualitative Interviewers will conduct 1 hour, phone-based cognitive interviews with clinicians to assess physicians' comprehension of items and response options on clinician reported pediatric sedation scales and clinician evaluation of the relevance of the scale to capture sedation levels.
- Conditions
- Pediatric Sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Clinicians - Group 1 | Pediatric clinical care clinicians who work with patients who are sedated for diagnostic or therapeutic procedures. May included, MDs, DOs, PharmDs, Nurse Practitioners, or nurses with a BSN or higher level nursing degree. This cohort will complete a first round of interviews to assess measure content. | |
| Pediatric Clinicians - Group 2 | Pediatric clinical care clinicians who work with patients who are sedated for diagnostic or therapeutic procedures. May included, MDs, DOs, PharmDs, Nurse Practitioners, or nurses with a BSN or higher level nursing degree. This smaller cohort will be a randomized subset of the original cohort and will complete interviews to assess changes made based on the feedback from the first cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of providers who expressed they agreed that all medically important levels of sedation are captured by the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.
Measured: 1 hour
Number of providers who expressed they understood individual sedation levels specified on the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.
Measured: 1 hour
Number of providers who expressed they understood how to complete the Pediatric Sedation State Scale and University of Michigan Sedation Scale with provided instructions as measured by a qualitative interview
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed. The Pediatric Sedation State Scale requires that a physician choose a level from 1 - 5 that corresponds to the patient's sedation level. The University of Michigan Sedation Scale requires that a physician choose a sedation level from 1 - 4 that corresponds to the patient's sedation level. The scales will not be completed by clinicians and will not be scored. The content of the qualitative interview is the "measure". The scales are not the measure in this study.
Measured: 1 hour
Number of providers who expressed any difficulty with comprehension of any of the text contained in the Pediatric Sedation State Scale or University of Michigan Sedation Scale as measured by a qualitative interview
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed. The Pediatric Sedation State Scale requires that a physician choose a level from 1 - 5 that corresponds to the patient's sedation level. The University of Michigan Sedation Scale requires that a physician choose a sedation level from 1 - 4 that corresponds to the patient's sedation level. The scales will not be completed by clinicians and will not be scored. The content of the qualitative interview is the "measure". The scales are not the measure in this study.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start15 Apr 2019
- Primary completion15 Nov 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric SedationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Christina Zigler, PhD, Principal investigator, Duke UniversityBryce B Reeve, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956342
- Sponsor's protocol ID
- Pro00102030
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2019
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside of the study team.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Clinician Reported Outcome (ClinRO) Measures of Pediatric Sedation
- ClinicalTrials.gov ID
- NCT03956342
- Acronym / sponsor ID
- Pro00102030
- Conditions
- Pediatric Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 20 May 2019 (actual)
- 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.
This study will conduct qualitative interviews to provide evidence for the content validity and comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia to facilitate a diagnostic or surgical procedure. Information gained from this study will inform the use of the measure in studies that are part of the PTN.
Detailed description
The primary objective of this study is to assess the content validity and physician understanding of the Pediatric Sedation State Scale (PSSS) and the University of Michigan Sedation Scale (UMSS) via cognitive interviewing methods. Qualitative Interviewers will conduct 1 hour, phone-based cognitive interviews with clinicians to assess physicians' comprehension of items and response options on clinician reported pediatric sedation scales and clinician evaluation of the relevance of the scale to capture sedation levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Clinicians - Group 1 | – | –Pediatric clinical care clinicians who work with patients who are sedated for diagnostic or therapeutic procedures. May included, MDs, DOs, PharmDs, Nurse Practitioners, or nurses with a BSN or higher level nursing degree. This cohort will complete a first round of interviews to assess measure content. |
| Pediatric Clinicians - Group 2 | – | –Pediatric clinical care clinicians who work with patients who are sedated for diagnostic or therapeutic procedures. May included, MDs, DOs, PharmDs, Nurse Practitioners, or nurses with a BSN or higher level nursing degree. This smaller cohort will be a randomized subset of the original cohort and will complete interviews to assess changes made based on the feedback from the first cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be practicing clinicians in a clinical care environment for whom >50% of their patients are sedated/anesthetized for diagnostic and/or therapeutic procedures. Clinicians may be an anesthesiologist, pediatric critical care physician, clinical pharmacist, physician assistant, nurse anesthetist, nurse practitioner, or other nurse with a BSN or higer.
Key inclusion criteria (14 listed)
- Is a practicing clinician in a clinical care environment
- Cares for pediatric patients >50% of their time
- Treats or works with pediatric patients who are sedated/anesthetized for diagnostic and/or therapeutic procedures
- Holds one of the following titles/positions
- Is over the age of 18 years
Key exclusion criteria (1 listed)
- 1. Lack of access to a telephone for interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of providers who expressed they agreed that all medically important levels of sedation are captured by the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview
Time frame: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.
Number of providers who expressed they understood individual sedation levels specified on the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview
Time frame: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed.
Number of providers who expressed they understood how to complete the Pediatric Sedation State Scale and University of Michigan Sedation Scale with provided instructions as measured by a qualitative interview
Time frame: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed. The Pediatric Sedation State Scale requires that a physician choose a level from 1 - 5 that corresponds to the patient's sedation level. The University of Michigan Sedation Scale requires that a physician choose a sedation level from 1 - 4 that corresponds to the patient's sedation level. The scales will not be completed by clinicians and will not be scored. The content of the qualitative interview is the "measure". The scales are not the measure in this study.
Number of providers who expressed any difficulty with comprehension of any of the text contained in the Pediatric Sedation State Scale or University of Michigan Sedation Scale as measured by a qualitative interview
Time frame: 1 hour
A 1 hour qualitative interview will be completed and coded to assess the quality of the measures being assessed. The Pediatric Sedation State Scale requires that a physician choose a level from 1 - 5 that corresponds to the patient's sedation level. The University of Michigan Sedation Scale requires that a physician choose a sedation level from 1 - 4 that corresponds to the patient's sedation level. The scales will not be completed by clinicians and will not be scored. The content of the qualitative interview is the "measure". The scales are not the measure in this study.
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 30 Dec 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside of the study team.
Related trials for Pediatric Sedation
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Not yet recruitingObservational study
Sugammadex Timing and Recovery Profile in Pediatric Adenotonsillectomy
Neuromuscular Blockade, Delayed Emergence From Anesthesia
Not yet recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Not yet recruitingPhase 1
Magnesium Sulfate in Pediatric Burn Dressing Changes
Pediatric Burns
Not yet recruitingPhase 3
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Delirium in the Intensive Care Unit
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.
Christina Zigler, PhD principal investigator
Duke University
Bryce B Reeve, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Sedation, run by Duke University 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 14 inclusion and 1 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 30 Dec 2019. 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?
Number of providers who expressed they agreed that all medically important levels of sedation are captured by the Pediatric Sedation State Scale and University of Michigan Sedation Scale as measured by a qualitative interview (time frame: 1 hour). The study lists 4 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 30 Dec 2019.