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

NCT05175976 | Completed

• 1 other identifier: K44YB21yi7
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety Issues

Keywords

patient safety; monitoring; Helsinki Declaration

Outcome Measures

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

  2 months

Secondary Outcomes (3)

• The use of clinical protocols

  2 months

• Keeping records of anesthesia complications

  2 months

• The use of the WHO Safe Surgery checklist

  2 months

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Experienced anesthesiologists from most regions of Ukraine were interviewed.

You may qualify if:

• experienced anesthesiologists

You may not qualify if:

• anesthesiologists out of practice

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Study Sites (1)

Bogomolets NMU

Kyiv, Ukraine

Location

Related Publications (8)

• 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.

  PMID: 21330916 BACKGROUND

• 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.

  PMID: 16582768 BACKGROUND

• 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.

  PMID: 20520556 BACKGROUND

• 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.

  PMID: 21785357 BACKGROUND

• 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.

  PMID: 31268913 BACKGROUND

• 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.

  PMID: 11809125 BACKGROUND

• 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.

  PMID: 12803354 BACKGROUND

• 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.

  PMID: 35624436 DERIVED

Study Officials

• Iurii Kuchyn, PhD

  Bogomolets National Medical University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 4, 2022
• Study Start: March 1, 2021
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)