NCT05435287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 28, 2022

Completed
Last Updated

June 28, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

June 23, 2022

Last Update Submit

June 23, 2022

Conditions

Keywords

patient safetycritical incidentanaesthesia

Outcome Measures

Primary Outcomes (1)

  • Critical Incident During Anaesthesia

    Critical Incident During Anaesthesia

    5 months

Secondary Outcomes (2)

  • The use of the WHO Safe Surgery checklist

    5 months

  • Keeping records of the critical incidents

    5 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients, who had critical incident during anesthesia.

You may qualify if:

  • 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

You may not qualify if:

  • critical incidents without aneasthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bogomolets NMU

Kyiv, Ukraine

Location

Related Publications (5)

  • Liu EH, Koh KF. A prospective audit of critical incidents in anaesthesia in a university teaching hospital. Ann Acad Med Singap. 2003 Nov;32(6):814-20.

    PMID: 14716952BACKGROUND
  • Agbamu, P.O Et...al (2016) Critical Incidents and Near Misses During Anaesthesia: a Prospective Audit.13th Annual Scientific, Conference and Gathering Held at College of Medicine, University of Lagos, Idi Araba.

    BACKGROUND
  • Amucheazi AO, Ajuzieogu OV. Critical incidents during anesthesia in a developing country: A retrospective audit. Anesth Essays Res. 2010 Jul-Dec;4(2):64-8. doi: 10.4103/0259-1162.73508.

    PMID: 25885231BACKGROUND
  • Ahluwalia J, Marriott L. Critical incident reporting systems. Semin Fetal Neonatal Med. 2005 Feb;10(1):31-7. doi: 10.1016/j.siny.2004.09.012.

    PMID: 15698968BACKGROUND
  • Bielka K, Kuchyn I, Frank M, Sirenko I, Yurovich A, Slipukha D, Lisnyy I, Soliaryk S, Posternak G. Critical incidents during anesthesia: prospective audit. BMC Anesthesiol. 2023 Jun 14;23(1):206. doi: 10.1186/s12871-023-02171-4.

Study Officials

  • Iurii Kuchyn, PhD

    Bogomolets National Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION

Study Record Dates

First Submitted

June 23, 2022

First Posted

June 28, 2022

Study Start

August 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 28, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations