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NCT Number: NCT05440331

Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Boulogne-Billancourt, 92100, France

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training with AnesList©

Other

Training with AnesList© as tool

Primary outcomes

  1. The occurence of adverse events

    Time frame: at 1 month

    Death, serious complications and re-hospitalization will be noted in order to evaluate the efficacy of standardized transmission with AnesList©.

Secondary outcomes

  1. The duration of ICU stay

    Time frame: through study completion, an average of 18 months

    The length of initial ICU stay will be noted.

  2. The duration of hospitalization

    Time frame: through study completion, an average of 18 months

    The length of initial hospitalization will be noted.

  3. Evaluate of the condition of transmission

    Time frame: through study completion, an average of 18 months

    By the presence or intervention of anaesthetics-nurse, recorded or not the transmission in medical files.

  4. Utilization of the AnesList© by anaesthesists at 6 months

    Time frame: at 6 months

    Only for intervention group: use on cell phone or with printed form: the use will be noted.

  5. Quality of medical transmission

    Time frame: 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.

  6. Interaction with study nurse

    Time frame: 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.

  7. Morbi-mortality

    Time frame: through study completion, an average of 18 months

    The method of chronological series will be used to analysis the morbi-mortality in investigator center.

Study contacts

Contact information is provided by the study sponsor or research team.

Aicha KASSOUL, MD

CONTACT

[email protected]

+ 33 (0)633855997

Dominique FLETCHER, MD, PhD

CONTACT

[email protected]

+33 (0)661177035

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Morbidity and Mortality in Operating Room: Surgery and Standardized Communication

Acronym: HIATUS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2022
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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