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

NCT ID: NCT05175976

Last Updated: 2022-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Safety Issues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* experienced anesthesiologists

Exclusion Criteria

* anesthesiologists out of practice
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bogomolets National Medical University

OTHER

Sponsor Role lead

Responsible Party

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Kateryna Bielka

Assistant professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iurii Kuchyn, PhD

Role: STUDY_DIRECTOR

Bogomolets National Medical University

Locations

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Bogomolets NMU

Kyiv, , Ukraine

Site Status

Countries

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Ukraine

References

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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.

Reference Type BACKGROUND
PMID: 21330916 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16582768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20520556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21785357 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31268913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11809125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12803354 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35624436 (View on PubMed)

Other Identifiers

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K44YB21yi7

Identifier Type: -

Identifier Source: org_study_id

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