Clinical trial NCT05440331: Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room
Official title: Morbidity and Mortality in Operating Room: Surgery and Standardized Communication
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Surgery
Keywords: Major surgery
Morbility
Mortality
Training in peroperative
Handover
Anaesthetist
Nurse anaesthetist
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients requiring urgent or planned major surgery (duration of surgery \> 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery; with 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.

Brief summary: The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.

Detailed description: The secondary objectives are:

* 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.

Eligibility criteria: Inclusion Criteria:

* Patient aged \> 18 years;
* 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:

* Transmission between physician anaesthesist and nurse anaesthetist;
* 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.

Primary outcomes:
measure: The occurence of adverse events
timeFrame: at 1 month
Secondary outcomes:
measure: The duration of ICU stay
timeFrame: through study completion, an average of 18 months
measure: The duration of hospitalization
timeFrame: through study completion, an average of 18 months
measure: Evaluate of the condition of transmission
timeFrame: through study completion, an average of 18 months
measure: Utilization of the AnesList© by anaesthesists at 6 months
timeFrame: at 6 months
measure: Quality of medical transmission
timeFrame: through study completion, an average of 18 months
measure: Interaction with study nurse
timeFrame: through study completion, an average of 18 months
measure: Morbi-mortality
timeFrame: through study completion, an average of 18 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
Study officials:
affiliation: Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
name: Dominique FLETCHER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP
name: Aicha KASSOUL, MD
role: STUDY_DIRECTOR
References:
citation: Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
citation: 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.
citation: 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.