ACUTE-FLOW: Surgical Emergency Flows and Delays in Admission to the Operating Room

Sponsor
University Hospital, Lille (Other)
Overall Status
Completed
CT.gov ID
NCT04585529
Collaborator
Société Française d'Anesthésie et de Réanimation (Other)
1,149
10
5.3
114.9
21.7

Study Details

Study Description

Brief Summary

French hospitals treat non-elective surgery according to three organizational models: in a dedicated multi-specialty emergency operative room (OR), in a dedicated OR within a specialized surgical platform or in any available OR from a list of non-dedicated OR. Some triage algorithms for the classification of non-elective surgery have been described but are not routinely applied. The rate of delay in the management of non-elective surgery in France is not known. Reducing this delay decreased mortality and morbidity in urgent surgery (McIsaac D, et al., CMAJ 2017). Optimizing the flow of non-elective surgery represents a major challenge. The main objective of this study is to determine the rate of delay in admission to the OR in emergency surgery through a multicenter prospective observational study in France. All patients requiring urgent surgical management (<72 hours) will be included. The ideal time for surgery was previously defined by surgeons according to the NEST classification (NEST 1: within minutes; NEST 2: < 1 hour; NEST 3: < 4 hours; NEST 4: < 12 hours; NEST 5: < 48 hours; NEST 6: < 72 hours). For each patient, the ratio between the observed time (actual Time To Surgery [aTTS] ) and the ideal time (ideal Time To Surgery [iTTS]) will be determined. The delay is identified by aTTS/iTTS ratio >1.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1149 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France
    Actual Study Start Date :
    Oct 5, 2020
    Actual Primary Completion Date :
    Mar 15, 2021
    Actual Study Completion Date :
    Mar 15, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of OR admission delay (delay = aTTS / iTTS > 1) [30 days]

      hours

    Secondary Outcome Measures

    1. OR Admission delay according to the three organizational model [30 days]

      hours

    2. OR Admission delay according to the period of work (day, night, and week-end) [30 days]

      hours

    3. OR Admission delay according to the NEST classification [30 days]

      hours

    4. delays related to organisational causes [30 days]

      hours

    5. delays related to material causes [30 days]

      hours

    6. delays related to human causes [30 days]

      hours

    7. Impact of the delay on ICU length of stay [30 days]

      days

    8. Impact of the delay on hospital length of stay [30 days]

      days

    9. Impact of the delay on mortality [30 days]

    10. Impact of the delay on morbidity [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    any patient meeting the Following two criteria

    • at least 18 ys old

    • decision for unplanned surgery (which should be performed within 72 hours according to the protocol)

    • in one of the following hospitals: Lille University hospital, Grenoble University hospital, Strasbourg University hospital, Paris University hospitals (Européen Georges Pompidou, Beaujon, H. Mondor), Lyon University hospital (Hôpital E. Herriot, Lyon Sud), Angers University hospital, Anthony Private hospital).

    Exclusion Criteria:
    • obstetrics

    • interventional radiology

    • endoscopies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital Angers France
    2 Clinique Antony France
    3 Beaujon Hospital Clichy France
    4 Henri Mondor Hospital Créteil France
    5 University Hospital Grenoble France
    6 University hospital Lille France
    7 Edouard Herriot Hospital Lyon France
    8 Hôpital sud Lyon France
    9 HEGP Paris France
    10 University Hospital Strasbourg France

    Sponsors and Collaborators

    • University Hospital, Lille
    • Société Française d'Anesthésie et de Réanimation

    Investigators

    • Principal Investigator: Delphine GARRIGUE, MD, University Hospital, Lille, France
    • Study Chair: Benoit TAVERNIER, MD, PhD, University Hospital, Lille, France

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04585529
    Other Study ID Numbers:
    • NI2020/01
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    May 26, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2021