Competence in Propofol Sedation for Endoscopy Clinical Trial
— NAPSATOfficial title:
A Reliable and Valid Assessment of Nurse Administered Propofol Sedation (NAPS) Performance.
| Verified date | September 2013 |
| Source | Copenhagen University Hospital at Herlev |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Dataprotection Agency |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | June 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - eligible nurses, written informed consent. Exclusion Criteria: - Prior anesthesia or ICU experience |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Herlev Hospital, Gastroenheden | Copenhagen, Herlev | Herlev |
| Lead Sponsor | Collaborator |
|---|---|
| Copenhagen University Hospital at Herlev |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessed sedation performance score | 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 | No |