Effectiveness, neuropsychological distress, teamwork, and ergonomics with procedures conducted in the i-Suite surgical environment

ISRCTN	ISRCTN94152783
DOI	https://doi.org/10.1186/ISRCTN94152783
Protocol serial number	ukb_6.1_2008
Sponsor	Unfallkrankenhaus Berlin Trauma Center (Germany)
Funders	Unfallkrankenhaus Berlin Trauma Center (main funding body) (Germany), Additional funding will be sought from Stryker (Germany)

Submission date: 31/03/2008
Registration date: 11/04/2008
Last edited: 11/04/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Axel Ekkernkamp
Scientific

Department of Orthopaedic and Trauma Surgery
Unfallkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany

Email	axel.ekkernkamp@ukb.de

Study information

Primary study design	Interventional
Study design	Single-centre, randomised controlled trial.
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ENTERPRISE
Study objectives	A novel, integrated operating theatre environment (i-Suite™, Stryker) reduces the average or time in trauma, orthopaedic, and visceral procedures (i.e., the time interval from the patient's entry to discharge from the theatre) compared to a modern, conventional operating room by 20 ± SD 50 minutes (equating a moderate Cohen's effect size of 0.4 = 20/50).
Ethics approval(s)	Institutional Review Board of the Charité University Medical Center. Date of approval: 06/02/2008 (ref: EA1/004/08)
Health condition(s) or problem(s) studied	All elective orthopedic and/or trauma, or visceral surgical procedures.
Intervention	Experimental intervention: General orthopedic (e.g., total joint replacement), trauma, and surgical procedures (e.g., fracture fixation, abdominal and thoracic surgery) conducted in one of two integrated i-Suite operating theatres. Control intervention: A similar range of procedures, conducted in a conventional, last-generation operating theatre.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Time interval from the patient's entry to discharge from the operating theatre.
Key secondary outcome measure(s)	1. Team-centered endpoints, recorded during operation: 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 1.2. Quantity and quality of distracting events (e.g., phone calls, door openings, technical failures) that may prolong or compromise the procedure 1.3. Comfort and climate (e.g., space, noise, and others) 1.4. Perceived success of the procedure 1.5. Team interaction 2. Patient-centered endpoints: 2.1. Critical incidents, intra- and post-operative complications, monitored during hospital stay until discharge 2.2. Quality of Life (EuroQol [EQ5D]) questionnaire at baseline, discharge and 6 months after surgery (by post)
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	400
Key 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
Key exclusion criteria	1. Acute, emergency, or life-saving surgery 2. Refusal of trial participation
Date of first enrolment	01/05/2008
Date of final enrolment	01/05/2009

Locations

Countries of recruitment

Germany

Study participating centre

Department of Orthopaedic and Trauma Surgery

Berlin
12683
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan