Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room (HIATUS)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Major Surgery

Treatments

Other: Training with AnesList©

Study type

Observational

Funder types

Other

Identifiers

NCT05440331
2022-A01109-34 (Registry Identifier)
APHP210992

Details and patient eligibility

About

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.

Full description

The secondary objectives are: to analysis the impact of the transmission on: the occurence of different events: re-hospitalization, serious complications, death at one month; the duration of initial ICU stay and of hospitalization; the duration of the transmission; 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.

Enrollment

1,120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,120 participants in 3 patient groups

Experimental group
Description:
Experimental group with training after randomization immediately
Treatment:
Other: Training with AnesList©
Control group with delayed training
Description:
Control group with training: the training will delayed from time of randomization
Treatment:
Other: Training with AnesList©
Control group without training
Description:
Control group without training

Trial contacts and locations

1

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Central trial contact

Dominique FLETCHER, MD, PhD; Aicha KASSOUL, MD

Data sourced from clinicaltrials.gov

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