Intraoperative WorkflowNCT00591435
Influence of Resident Training on Intra-operative Workflow
An observational study of Intraoperative Workflow and Anesthesia and Procedure Related Time Intervals, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
Anaesthesia and surgery related time intervals of three standard operations are compared depending on whether residents or consultants are performing anaesthesia and surgery. Hypothesis: Perioperative workflow is influenced by state of education, time intervals reflecting anaesthesia as well as surgical performance… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraoperative Workflow, Anesthesia and Procedure Related Time Intervals
- What is being tested?
- Comparison of performance of consultants versus residents
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Dec 2007
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia
Who may be able to join
- Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia
Who cannot join
- Patient's refusal of data collection, emergency procedures, change of physician in charge (resident to consultant or the other way around) of anesthesia or surgical team
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Schleswig-Holstein, 24105
About this study
Official title: Resident Training Affects Intra-Operative Workflow and Costs
Anaesthesia and surgery related time intervals of three standard operations are compared depending on whether residents or consultants are performing anaesthesia and surgery.
Hypothesis: Perioperative workflow is influenced by state of education, time intervals reflecting anaesthesia as well as surgical performance increase due to resident training. Therefore, costs of perioperative care increase as well.
- Being tested
- Comparison of performance of consultants versus residents
- Keywords
- Anesthesia, Surgery, Education, Economics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of performance of consultants versus residentsOther
Anesthesia as well as surgical workflow will be analysed. Performance of consultants will be compared to residents
| Study group | Role | What they receive |
|---|---|---|
| 1 | 200 laparoscopic cholecystectomies will be included, consultant cases will be compared to resident cases Receives: Other: Comparison of performance of consultants versus residents | |
| 2 | 200 laparoscopic pelviscopies will be included, consultant cases will be compared to resident cases Receives: Other: Comparison of performance of consultants versus residents | |
| 3 | 200 transurethral resection of urinary bladder or prostate gland will be included, consultant cases will be compared to resident cases Receives: Other: Comparison of performance of consultants versus residents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaesthesia and procedural related time intervals
Measured: All events will be recorded intraoperativly
Secondary outcomes (1)
OR costs are calculated as $ 15.00 per minute, additional costs due to increase of time intervals will be analyzed
Measured: All data will be recorded intraoperaitvly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative WorkflowStudies 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
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anaesthesiology and Intensive Care Medicine
- Investigators
- Jens Scholz, MD, Professor, Principal investigator, Department of Anaesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591435
- Sponsor's protocol ID
- UKSH_Hanss
- Other IDs
- IRB: A138/07
- Status last verified
- Nov 2007
- First submitted
- 28 Dec 2007
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resident Training Affects Intra-Operative Workflow and Costs
- ClinicalTrials.gov ID
- NCT00591435
- Acronym / sponsor ID
- UKSH_Hanss
- Keywords
- Anesthesia, Surgery, Education, Economics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Department of Anaesthesiology and Intensive Care Medicine
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Jan 2008 (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.
Anaesthesia and surgery related time intervals of three standard operations are compared depending on whether residents or consultants are performing anaesthesia and surgery.
Hypothesis: Perioperative workflow is influenced by state of education, time intervals reflecting anaesthesia as well as surgical performance increase due to resident training. Therefore, costs of perioperative care increase as well.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Comparison of performance of consultants versus residents200 laparoscopic cholecystectomies will be included, consultant cases will be compared to resident cases |
| 2 | – | Other: Comparison of performance of consultants versus residents200 laparoscopic pelviscopies will be included, consultant cases will be compared to resident cases |
| 3 | – | Other: Comparison of performance of consultants versus residents200 transurethral resection of urinary bladder or prostate gland will be included, consultant cases will be compared to resident cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia
Key inclusion criteria (1 listed)
- Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia
Key exclusion criteria (1 listed)
- Patient's refusal of data collection, emergency procedures, change of physician in charge (resident to consultant or the other way around) of anesthesia or surgical team
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 |
|---|---|---|
| Comparison of performance of consultants versus residentsAnesthesia as well as surgical workflow will be analysed. Performance of consultants will be compared to residents | Other | 1, 2, 3 |
Primary outcome
Anaesthesia and procedural related time intervals
Time frame: All events will be recorded intraoperativly
1 secondary outcome
OR costs are calculated as $ 15.00 per minute, additional costs due to increase of time intervals will be analyzed
Time frame: All data will be recorded intraoperaitvly
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 24 Mar 2010.
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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.
Jens Scholz, MD, Professor principal investigator
Department of Anaesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel
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 Intraoperative Workflow and Anesthesia and Procedure Related Time Intervals, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 24 Mar 2010. 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 Germany. 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?
Anaesthesia and procedural related time intervals (time frame: All events will be recorded intraoperativly). 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 24 Mar 2010.