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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05440331

Collaborator

(none)

1,120

Enrollment

Location

Arms

Anticipated Duration (Months)

38.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Surgery	Other: Training with AnesList©	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Experimental group with training after randomization immediately	Other: Training with AnesList© Training with AnesList© as tool
Active Comparator: 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
No Intervention: Control group without training Control group without training

Arm

Intervention/Treatment

Experimental: Experimental group

Experimental group with training after randomization immediately

Other: Training with AnesList©

Training with AnesList© as tool

Active Comparator: 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

No Intervention: Control group without training

Control group without training

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP	Boulogne-Billancourt		France	92100

Sponsors and Collaborators

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