Critical Incident During Anaesthesia

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues; Critical Incident

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 Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Bogomolets NMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients, who had critical incident during anesthesia.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical Incident During Anaesthesia	Critical Incident During Anaesthesia	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The use of the WHO Safe Surgery checklist	The use of the WHO Safe Surgery checklist	5 months
Keeping records of the critical incidents	Keeping records of the critical incidents during anaesthesia	5 months

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: anaesthesia; patient safety; critical incident
• Other Study ID Numbers: B77KL32iv5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No