Understanding the Hawthorne effect.
Philip Sedgwick, Nan Greenwood
https://pubmed.ncbi.nlm.nih.gov/26341898Actively Recruiting
Age: 18Years +
All Genders
ID05440331
Morbidity and Mortality in Operating Room: Surgery and Standardized Communication
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-19
1120
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a standardized handover tool called AnesList during the transition between anesthesiologists in the operating room for patients undergoing major surgery. The main goal is to see if using AnesList reduces serious events like death, complications, or rehospitalization within one month after surgery. The study also aims to assess the impact of this communication on hospital and ICU stay lengths, transmission quality, and overall morbidity and mortality at participating centers. Participants are assigned to one of three groups: an experimental group receiving immediate training on AnesList , a control group with delayed training, and a control group without training. The study observes how anesthesiologists use AnesList and evaluates training satisfaction and obstacles to its use. Follow-up includes monitoring the continued use of the tool six months after enrollment ends. During the study, researchers collect data on adverse events one month after surgery, duration of ICU and hospital stays, quality and condition of handovers, and interaction with study nurses, averaging 18 months of follow-up. Satisfaction with the tool and its training is also assessed. Participants are monitored for morbidity and mortality outcomes before, during, and after the study period to evaluate the effectiveness of standardized communication in the operating room.
CONDITIONS
Brief Title
Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient aged > 18 years
- Patients with ASA score I-IV
- Requiring urgent or planned surgery
- Major surgery lasting more than 2 hours and requiring at least one night hospital stay (orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery)
- Handover between two physician anesthesiologists in the operating room
- Intensive care anesthesiologists and nurse anesthetists working in investigator center during the study
- Affiliated to a social security system
- No opposition to participating in the study
You will not qualify if you...
- Transmission between physician anesthesiologist and nurse anesthetist
- Medical transmission occurring outside anesthesia care or outside operating room
- Medical transmission occurring in a transitory manner (e.g., coffee time, lunch time)
- Patients enrolled in another ongoing surgical intervention study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Duration of surgery and immediate post-operative period
Participants undergo major surgery lasting more than 2 hours requiring at least one night hospital stay and experience handover between anesthesiologists in the operating room.
1 surgical visit and immediate post-operative observation
Monitoring
Duration - Up to 18 months
Participants are observed for adverse events including re-hospitalization, serious complications, and mortality as well as duration of ICU stay and hospitalization.
Regular monitoring visits through study completion
Long-term Monitoring
Duration - Up to 6 months after inclusion ends
Participants’ use of the AnesList© tool and quality of medical transmission are evaluated, along with satisfaction and interaction with study staff.
Follow-up assessments at 6 months
Trial Site Locations
Total: 1 location
1
Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Boulogne-Billancourt, France, 92100
Actively Recruiting
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Research Team
D
Dominique FLETCHER, MD, PhD
A
Aicha KASSOUL, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists.
Marion Jullia, Anaïs Tronet, Fabiola Fraumar...
https://pubmed.ncbi.nlm.nih.gov/28437261A surgical safety checklist to reduce morbidity and mortality in a global population.
Alex B Haynes, Thomas G Weiser, William R Berry...
https://pubmed.ncbi.nlm.nih.gov/19144931