CClinicalTrials.gg
CompletedNCT05175976Updated Jan 4, 2022

Patient Safety in the Operating Room: Helsinki Declaration Implementation in Ukraine

An observational study in Safety Issues, sponsored by Bogomolets National Medical University. Completed at 1 site in Ukraine. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Bogomolets National Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
176
Ages
25 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Safety Issues

Keywords

  • patient safety
  • monitoring
  • Helsinki Declaration
03

In context

Lead sponsor

Bogomolets National Medical University is the lead sponsor of 37 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Experienced anesthesiologists from most regions of Ukraine were interviewed.

Inclusion criteria

  • experienced anesthesiologists

Exclusion criteria

Exclusion Criteria:

  • anesthesiologists out of practice
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
176 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. The implication of the Helsinki Declaration on Patient Safety in the hospital

    The implication of the Helsinki Declaration on Patient Safety in hospital

    Time frame: 2 months

Secondary outcomes

  1. The use of clinical protocols

    The use of clinical protocols

    Time frame: 2 months

  2. Keeping records of anesthesia complications

    Keeping records of anesthesia complications

    Time frame: 2 months

  3. The use of the WHO Safe Surgery checklist

    The use of the WHO Safe Surgery checklist

    Time frame: 2 months

07

Study locations

1 site
  • Bogomolets NMU
    Kyiv, Ukraine
08

References and documents

Publications

  • Staender SE, Mahajan RP. Anesthesia and patient safety: have we reached our limits? Curr Opin Anaesthesiol. 2011 Jun;24(3):349-53. doi: 10.1097/ACO.0b013e328344d90c. PubMed 21330916 ↗
  • Horton JB, Reece EM, Broughton G 2nd, Janis JE, Thornton JF, Rohrich RJ. Patient safety in the office-based setting. Plast Reconstr Surg. 2006 Apr;117(4):61e-80e. doi: 10.1097/01.prs.0000204796.65812.68. PubMed 16582768 ↗
  • 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. PubMed 20520556 ↗
  • Balzer F, Spies C, Schaffartzik W, Pappert D, Wernecke KD, Kuhly R, Boemke W. Patient safety in anaesthesia: assessment of status quo in the Berlin-Brandenburg area, Germany. Eur J Anaesthesiol. 2011 Oct;28(10):749-52. doi: 10.1097/EJA.0b013e328348ee35. No abstract available. PubMed 21785357 ↗
  • Wu HHL, Lewis SR, Cikkelova M, Wacker J, Smith AF. Patient safety and the role of the Helsinki Declaration on Patient Safety in Anaesthesiology: A European survey. Eur J Anaesthesiol. 2019 Dec;36(12):946-954. doi: 10.1097/EJA.0000000000001043. PubMed 31268913 ↗
  • 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. PubMed 11809125 ↗
  • Kelley K, Clark B, Brown V, Sitzia J. Good practice in the conduct and reporting of survey research. Int J Qual Health Care. 2003 Jun;15(3):261-6. doi: 10.1093/intqhc/mzg031. PubMed 12803354 ↗
  • 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. PubMed 35624436 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05175976
Lead sponsor
Bogomolets National Medical University
Responsible party
Kateryna Bielka (Assistant professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION, Bogomolets National Medical University) — Principal investigator
First posted
Jan 4, 2022
Start date
Mar 1, 2021
Primary completion
Apr 1, 2021
Completion
Sep 1, 2021
Last update
Jan 4, 2022

Study contacts

Iurii Kuchyn, PhD
study director · Bogomolets National Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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