Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

NCT05440331 | Recruiting

• 2 other identifiers: APHP2109922022-A01109-34
• Study Type: observational
• Target: 1,120
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Surgery

Keywords

Major surgery; Morbility; Mortality; Training in peroperative; Handover; Anaesthetist; Nurse anaesthetist

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The duration of ICU stay

  through study completion, an average of 18 months

• The duration of hospitalization

  through study completion, an average of 18 months

• Evaluate of the condition of transmission

  through study completion, an average of 18 months

• Utilization of the AnesList© by anaesthesists at 6 months

  at 6 months

• Quality of medical transmission

  through study completion, an average of 18 months

Study Arms (3)

Experimental group

Experimental group with training after randomization immediately

Other: Training with AnesList©

Control group with delayed training

Control group with training: the training will delayed from time of randomization

Other: Training with AnesList©

Control group without training

Control group without training

Interventions

Training with AnesList© OTHER

Training with AnesList© as tool

Control group with delayed training; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

Boulogne-Billancourt, 92100, France

RECRUITING

Related Publications (3)

• Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.

  PMID: 26341898 BACKGROUND

• 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.

  PMID: 28437261 BACKGROUND

• 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.

  PMID: 19144931 BACKGROUND

Study Officials

• Dominique FLETCHER, MD, PhD

  Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

  PRINCIPAL INVESTIGATOR

• Aicha KASSOUL, MD

  Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

  STUDY DIRECTOR

Central Study Contacts

Dominique FLETCHER, MD, PhD

CONTACT

+33 (0)661177035; dominique.fletcher@aphp.fr

Aicha KASSOUL, MD

CONTACT

+ 33 (0)633855997; aicha.kassoul@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 30, 2022
• Study Start: September 8, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)