Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room
NCT ID: NCT05440331
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1120 participants
OBSERVATIONAL
2023-09-08
2026-10-31
Brief Summary
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Detailed Description
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* to analysis the impact of the transmission on:
1. the occurence of different events: re-hospitalization, serious complications, death at one month;
2. the duration of initial ICU stay and of hospitalization;
3. the duration of the transmission;
4. the quality of the transmission by the physician leaving operating room.
* to evaluate the condition of the transmission
* to study the persistence of the use of the AnesList© at 6 months after the end of inclusions in the center
* to evaluate the satisfaction on AnesList© and on the training with the tool and the obstacles of its utilization
* to evaluate the morbility-mortality in the centers of the centers before, during and 6 months after the beginning of the study.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Experimental group
Experimental group with training after randomization immediately
Training with AnesList©
Training with AnesList© as tool
Control group with delayed training
Control group with training: the training will delayed from time of randomization
Training with AnesList©
Training with AnesList© as tool
Control group without training
Control group without training
No interventions assigned to this group
Interventions
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Training with AnesList©
Training with AnesList© as tool
Eligibility Criteria
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Inclusion Criteria
* Patients with score ASA I-IV;
* Requiring urgent or planned surgery;
* Major surgery (duration of surgery \> 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery;
* Handover between two anesthesists defined as a definitive relay between one physician anaesthesist and another in operating room;
* Intensive care anesthesists and nurse anaesthetist working in investigator center during the study;
* Affiliated to a social security system;
* No-opposition to participating to the study.
Exclusion Criteria
* Medical transmission occurs out of anesthesia care out of operating room;
* Medical transmission occurs in transitory manner (for example: coffee time, lunch time);
* Patients enrolled in an another ongoing study of surgical intervention.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Dominique FLETCHER, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Aicha KASSOUL, MD
Role: STUDY_DIRECTOR
Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Locations
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Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Boulogne-Billancourt, , France
Countries
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Central Contacts
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References
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Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. 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. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.
Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
Other Identifiers
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2022-A01109-34
Identifier Type: REGISTRY
Identifier Source: secondary_id
APHP210992
Identifier Type: -
Identifier Source: org_study_id
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