- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768143
Assessment of NAPS Performance. (NAPSAT)
August 19, 2014 updated by: Copenhagen University Hospital at Herlev
A Reliable and Valid Assessment of Nurse Administered Propofol Sedation (NAPS) Performance.
To measure competencies in propofol sedation for endoscopic procedures (NAPS)through development, test and validation of a reliable assessment tool in a simulator setting.
Hypothesis: That the tool will demonstrate content and construct validity, ie. enable reliable measuring of necessary competencies of different levels in a reproducible way.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Herlev
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Copenhagen, Herlev, Herlev, Denmark, 2730
- Herlev Hospital, Gastroenheden
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Endoscopy nurses of different competencylevel
Description
Inclusion Criteria:
- eligible nurses, written informed consent.
Exclusion Criteria:
- Prior anesthesia or ICU experience
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Nurse Trainees
unexperienced endoscopy nurses
|
|
|
Nurse Experts
Educated endoscopy Nurses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessed sedation performance score
Time Frame: 6 months
|
A Total of 12 Global Rating Scores and 2 checklist scores on hands on performance in a simulation setting and a theoretical Multiple Choice questionnaire.
The performance score is decided by independent raters who review performances on video.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
January 9, 2013
First Submitted That Met QC Criteria
January 11, 2013
First Posted (Estimate)
January 15, 2013
Study Record Updates
Last Update Posted (Estimate)
August 20, 2014
Last Update Submitted That Met QC Criteria
August 19, 2014
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SPAT-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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