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

Completed

• Conditions: Safety Issues

• Registration Number: NCT05175976
• Lead Sponsor: Bogomolets National Medical University

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-09-01
• Study First Submitted: 2021-11-30
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-28
• Last Update Submitted: 2021-12-28
• Study First Posted: 2022-01-04
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• experienced anesthesiologists

Exclusion Criteria

• anesthesiologists out of practice

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The implication of the Helsinki Declaration on Patient Safety in the hospital	2 months	The implication of the Helsinki Declaration on Patient Safety in hospital

Secondary Outcome Measures

Name	Time	Method
Keeping records of anesthesia complications	2 months	Keeping records of anesthesia complications
The use of clinical protocols	2 months	The use of clinical protocols
The use of the WHO Safe Surgery checklist	2 months	The use of the WHO Safe Surgery checklist

Trial Locations

Locations (1)

Bogomolets NMU; 🇺🇦 Kyiv, Ukraine