Critical Incident During Anaesthesia

Sponsor
Bogomolets National Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT05435287
Collaborator
(none)
92
1
5
18.4

Study Details

Study Description

Brief Summary

A multicenter study in Ukrainian hospitals on compliance with the requirements for responding to critical cases in the operating room, and the availability of relevant documentation and checklists.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Timely information and response to emergencies are important both in the context of patient safety and in the context of the hospital economy. The availability of information systems is one of the security requirements of the Helsinki Declaration of Patient Safety.

    Ukraine has only just begun its path to implementing the Declaration of Helsinki in Ukrainian hospitals. The level of adherence to the recommendations can vary considerably depending on the region, the provision of the hospital and the effectiveness of the institution's internal management. In our survey of Ukrainian hospitals, only 74% of hospitals kept records of anaesthesia complications in general, with only 46% having separate electronic or paper documents to record complications; Also, the majority of respondent physicians (62.9%) reported the absence of checklists or algorithms for actions in case of emergencies or emergencies during anaesthesia.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    92 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Critical Incident During Anaesthesia
    Actual Study Start Date :
    Aug 1, 2021
    Actual Primary Completion Date :
    Dec 31, 2021
    Actual Study Completion Date :
    Dec 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Critical Incident During Anaesthesia [5 months]

      Critical Incident During Anaesthesia

    Secondary Outcome Measures

    1. The use of the WHO Safe Surgery checklist [5 months]

      The use of the WHO Safe Surgery checklist

    2. Keeping records of the critical incidents [5 months]

      Keeping records of the critical incidents during anaesthesia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • critical incident during anaesthesia: massive hemorrhage >1000ml, difficult intubation, severe hypotension, severe bradycardia, desaturation, cardiac arrest, high spinal block, anesthetic toxicity, miocardial ischemia, severe arhytmia etc
    Exclusion Criteria:
    • critical incidents without aneasthesia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bogomolets NMU Kyiv Ukraine

    Sponsors and Collaborators

    • Bogomolets National Medical University

    Investigators

    • Study Director: Iurii Kuchyn, PhD, Bogomolets National Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kateryna Bielka, Associated professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION, Bogomolets National Medical University
    ClinicalTrials.gov Identifier:
    NCT05435287
    Other Study ID Numbers:
    • B77KL32iv5
    First Posted:
    Jun 28, 2022
    Last Update Posted:
    Jun 28, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kateryna Bielka, Associated professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION, Bogomolets National Medical University

    Study Results

    No Results Posted as of Jun 28, 2022