Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

Major Surgery Clinical Trial

— HIATUS  

Official title:

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05440331
• Other study ID #: APHP210992
• Secondary ID: 2022-A01109-34
• Status: Recruiting
• Start date: September 8, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Dominique FLETCHER, MD, PhD
• Phone: +33 (0)661177035
• Email: dominique.fletcher[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1120
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Major Surgery

Intervention

Other:
• Training with AnesList©
Training with AnesList© as tool

Locations

Country	Name	City	State
France	Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The duration of ICU stay	The length of initial ICU stay will be noted.	through study completion, an average of 18 months
Secondary	The duration of hospitalization	The length of initial hospitalization will be noted.	through study completion, an average of 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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