Clinical trial NCT05435287: Critical Incident During Anaesthesia
Official title: Critical Incident During Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Incident
Safety Issues
Keywords: patient safety
critical incident
anaesthesia
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, who had critical incident during anesthesia.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Critical Incident During Anaesthesia
timeFrame: 5 months
Secondary outcomes:
measure: The use of the WHO Safe Surgery checklist
timeFrame: 5 months
measure: Keeping records of the critical incidents
timeFrame: 5 months
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Bogomolets NMU
Study officials:
affiliation: Bogomolets National Medical University
name: Iurii Kuchyn, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.