Clinical trial NCT05175976: Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine
Official title: Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Safety Issues
Keywords: patient safety
monitoring
Helsinki Declaration
Lead sponsor: Bogomolets National Medical University
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 176
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Experienced anesthesiologists from most regions of Ukraine were interviewed.

Brief summary: Athe study to evaluate the implementation of the components of the Declaration of Helsinki in Ukrainian hospitals, as well as other safety measures during surgeries.

Detailed description: A study was conducted from May 2021 to September 2021 at the Ukrainian hospitals. The study design was approved by the Ethical Committee at Bogomolets National Medical University. The survey was conducted by filling out a standard Google form. The link to the survey was distributed on the official page of the Association of Anesthesiologists of Ukraine, through social networks Facebook and Instagram on the official webpages of the Department of Surgery, Anesthesiology and Intensive Care of the Institute of Postgraduate Education of NMU. O.O. Worshipers. A total of 174 respondents took part in the survey.

To conduct the survey, we formed a questionnaire of 24 items. The questionnaire was designed to ensure sufficient collection of data from respondents on demographics, awareness of the Declaration, and the use in the everyday practice of the measures recommended in it to promote patient safety. However, the structure of the questionnaire allowed people to fill it in a short time. We also provided respondents with more descriptive and detailed answers to some questions if they wished. The survey was conducted in Ukrainian. Practitioners-anesthesiologists, as well as heads of departments, employees of departments, were invited to participate in the survey.

The survey results were imported into a Microsoft Excel spreadsheet for further analysis. Simple descriptive statistics were used for demographic data and numerical answers to individual questions. The answers, which included the free text were grouped by topic using simple qualitative techniques.

Eligibility criteria: Inclusion Criteria:

* experienced anesthesiologists

Exclusion Criteria:

* anesthesiologists out of practice

Primary outcomes:
measure: The implication of the Helsinki Declaration on Patient Safety in the hospital
timeFrame: 2 months
Secondary outcomes:
measure: The use of clinical protocols
timeFrame: 2 months
measure: Keeping records of anesthesia complications
timeFrame: 2 months
measure: The use of the WHO Safe Surgery checklist
timeFrame: 2 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:
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citation: Mellin-Olsen J, Staender S, Whitaker DK, Smith AF. The Helsinki Declaration on Patient Safety in Anaesthesiology. Eur J Anaesthesiol. 2010 Jul;27(7):592-7. doi: 10.1097/EJA.0b013e32833b1adf.
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citation: McColl E, Jacoby A, Thomas L, Soutter J, Bamford C, Steen N, Thomas R, Harvey E, Garratt A, Bond J. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technol Assess. 2001;5(31):1-256. doi: 10.3310/hta5310. No abstract available.
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citation: Bielka K, Kuchyn I, Semenko N, Kashchii U, Pliuta I. Patient safety during anesthesia in Ukraine: national audit results. BMC Anesthesiol. 2022 May 27;22(1):164. doi: 10.1186/s12871-022-01704-7.