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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175976
• Other study ID #: K44YB21yi7
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: December 2021
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: September 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

Inclusion Criteria:

• experienced anesthesiologists

Exclusion Criteria:

• anesthesiologists out of practice

Related Conditions & MeSH terms

• Safety Issues

Locations

Country	Name	City	State
Ukraine	Bogomolets NMU	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View 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. Review. — View 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. — View Citation

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. Review. — View Citation

Wu HHL, Lewis SR, Cikkelová 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The use of clinical protocols	The use of clinical protocols	2 months
Secondary	Keeping records of anesthesia complications	Keeping records of anesthesia complications	2 months
Secondary	The use of the WHO Safe Surgery checklist	The use of the WHO Safe Surgery checklist	2 months