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

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

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.

Study Overview

• Status: Recruiting
• Conditions: Major Surgery
• Intervention / Treatment: Other: Training with AnesList©

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.

• Study Type: Observational
• Enrollment (Estimated): 1120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominique FLETCHER, MD, PhD; Phone Number: +33 (0)661177035; Email: dominique.fletcher@aphp.fr
• Study Contact Backup: Name: Aicha KASSOUL, MD; Phone Number: + 33 (0)633855997; Email: aicha.kassoul@aphp.fr

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Recruiting
    • Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental group; Experimental group with training after randomization immediately	Other: 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	Other: Training with AnesList©; Training with AnesList© as tool
Control group without training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The occurence of adverse events	Death, serious complications and re-hospitalization will be noted in order to evaluate the efficacy of standardized transmission with AnesList©.	at 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of ICU stay	The length of initial ICU stay will be noted.	through study completion, an average of 18 months
The duration of hospitalization	The length of initial hospitalization will be noted.	through study completion, an average of 18 months
Evaluate of the condition of transmission	By the presence or intervention of anaesthetics-nurse, recorded or not the transmission in medical files.	through study completion, an average of 18 months
Utilization of the AnesList© by anaesthesists at 6 months	Only for intervention group: use on cell phone or with printed form: the use will be noted.	at 6 months
Quality of medical transmission	Scale will be noted by anaesthesists between 0 and 22: 20% of recorded transmission will be noted.	through study completion, an average of 18 months
Interaction with study nurse	The study nurse will evaluate the existence and composite of the interaction between the anesthesist who receiving the transmission and the nurse.	through study completion, an average of 18 months
Morbi-mortality	The method of chronological series will be used to analysis the morbi-mortality in investigator center.	through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Dominique FLETCHER, MD, PhD, Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP; Study Director: Aicha KASSOUL, MD, Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Mortality; Anaesthetist; Major surgery; Handover; Morbility; Training in peroperative; Nurse anaesthetist
• Other Study ID Numbers: APHP210992; 2022-A01109-34 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No