Competence in Propofol Sedation for EndoscopyNAPSATNCT01768143
Assessment of NAPS Performance.
An observational study of Competence in Propofol Sedation for Endoscopy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Competence in Propofol Sedation for Endoscopy
- What is being tested?
- unexperienced endoscopy nurses and Experienced endoscopy nurses
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Jun 2013
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endoscopy nurses of different competencylevel
Who may be able to join
- eligible nurses, written informed consent.
Who cannot join
- Prior anesthesia or ICU experience
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- unexperienced endoscopy nurses, Experienced endoscopy nurses
- Keywords
- Propofol, Sedation, Endoscopy, nonanesthesiologist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unexperienced endoscopy nursesBehavioural
Experienced endoscopy nursesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nurse Trainees | unexperienced endoscopy nurses Receives: Behavioral: unexperienced endoscopy nurses | |
| Nurse Experts | Educated endoscopy Nurses Receives: Behavioral: Experienced endoscopy nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Competence in Propofol Sedation for EndoscopyStudies of the same condition, open and under way.
- 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768143
- Sponsor's protocol ID
- SPAT-003
- Acronym
- NAPSAT
- Status last verified
- Sep 2013
- First submitted
- 9 Jan 2013
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reliable and Valid Assessment of Nurse Administered Propofol Sedation (NAPS) Performance.
- ClinicalTrials.gov ID
- NCT01768143
- Acronym / sponsor ID
- NAPSAT / SPAT-003
- Keywords
- Propofol, Sedation, Endoscopy, nonanesthesiologist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Jan 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Trainees | – | Behavioral: unexperienced endoscopy nursesunexperienced endoscopy nurses |
| Nurse Experts | – | Behavioral: Experienced endoscopy nursesEducated endoscopy Nurses |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endoscopy nurses of different competencylevel
Key inclusion criteria (1 listed)
- eligible nurses, written informed consent.
Key exclusion criteria (1 listed)
- Prior anesthesia or ICU experience
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 |
|---|---|---|
| unexperienced endoscopy nurses | Behavioural | Nurse Trainees |
| Experienced endoscopy nurses | Behavioural | Nurse Experts |
Primary outcome
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.
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 20 Aug 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Competence in Propofol Sedation for Endoscopy, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
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 1 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 20 Aug 2014. 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 Denmark. 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?
Assessed sedation performance score (time frame: 6 months). 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 20 Aug 2014.