Effect of WHO Surgical Safety Checklist and Anesthesia Equipment Checklist on Patients Outcomes in Low-resource Settings.

Completed

• Conditions: Safety Issues

• Registration Number: NCT05798000
• Lead Sponsor: Bogomolets National Medical University

Brief Summary

The study to investigate the effectiveness and the current perception of safety checklists in Ukrainian hospitals.

Detailed Description

A prospective multicenter study was conducted in 6 large Ukrainian hospitals: Kyiv City Clinical Hospitals #1, University Clinic of the Bogomolets National Medical University, Kyiv City Maternity Hospital #5, National Cancer Institute, Shalimov National Institute of Surgery and Transplantology, Saint Martin Hospital in Mukachevo. Institutions were selected among those, where surgical department administration was willing to implement the Safe Surgery Saves Lives campaign recommendations, but has not yet formally introduced the WHO Safe Surgery Checklist. On each study site, 1 or 2 operating rooms were designated for data collection. All surgical procedures observed by the data collectors in those operating rooms were included. The study was conducted in two phases: control period, lasting from February 1, 2022 until August 1, 2022, followed by a week-long educational period during which the WHO Surgical Safety Checklist and the Anesthesia Equipment Checklist were used but no data were collected. The intervention period began on August 8, 2022 and lasted until December 31, 2022. Hospital administration and members of all surgical teams were informed of the nature of the study and the proper checklist use method by the involved anesthesiologists, who were previously instructed by the primary investigators. WHO Surgical Safety Checklists and the Anesthesia Equipment Checklists were provided in the designated operating rooms. Both checklists were translated into Ukrainian. The requirement for written informed consent from the patient was waived by the ethical committee of Bogomolets National Medical University. The study design was approved by the ethics committee of the Bogomolets National Medical University (protocol #148, 07.09.2021).

Study Timeline

• Study Start: 2022-02-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

• medical institutions with surgical departments

Exclusion Criteria

• medical institutions without surgical departments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	28 days	Postoperative mortality during 28 days after surgery
Recorded critical incidents during the procedure	24 hours	Recorded critical incidents during the procedure (hypotension, hypertension etc.)

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	1 months	Postoperative complications (bleeding, surgical infection etc.)

Trial Locations

Locations (1)

Bogomolets NMU; 🇺🇦 Kyiv, Ukraine