Effectiveness, neuropsychological distress, teamwork, and ergonomics with procedures conducted in the i-Suite surgical environment
Completed
- Conditions
- All elective orthopedic and/or trauma, or visceral surgical procedures.SurgeryN/A
- Registration Number
- ISRCTN94152783
- Lead Sponsor
- nfallkrankenhaus Berlin Trauma Center (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Inclusion Criteria
1. Consecutive patients >=18 years of age scheduled for orthopedic and/or trauma, or visceral surgery on weekdays between 8.00 am and 4.00 pm (core working hours)
2. Full ability to provide written informed consent
3. Both men and women
Exclusion Criteria
1. Acute, emergency, or life-saving surgery
2. Refusal of trial participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time interval from the patient's entry to discharge from the operating theatre.
- Secondary Outcome Measures
Name Time Method 1. Team-centered endpoints, recorded during operation:<br>1.1. Stress of surgeons, anaesthetists, and scrub nurses in charge, as measured by short questionnaire assessments and biological markers in saliva (cortisol and beta-endorphine) immediately before and after surgery<br>1.2. Quantity and quality of distracting events (e.g., phone calls, door openings, technical failures) that may prolong or compromise the procedure <br>1.3. Comfort and climate (e.g., space, noise, and others)<br>1.4. Perceived success of the procedure<br>1.5. Team interaction<br><br>2. Patient-centered endpoints:<br>2.1. Critical incidents, intra- and post-operative complications, monitored during hospital stay until discharge <br>2.2. Quality of Life (EuroQol [EQ5D]) questionnaire at baseline, discharge and 6 months after surgery (by post)