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

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

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

Study Overview

• Status: Completed
• Conditions: Safety Issues

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 Type: Observational
• Enrollment (Actual): 2200

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • Bogomolets NMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Institutions, 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.

Description

Inclusion Criteria:

• medical institutions with surgical departments

Exclusion Criteria:

• medical institutions without surgical departments

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; The control group without WHO and equipment checklist used
Study; Other group, where WHO safety check-list and equipment check-list were implemented

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recorded critical incidents during the procedure	Recorded critical incidents during the procedure (hypotension, hypertension etc.)	24 hours
Mortality	Postoperative mortality during 28 days after surgery	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Postoperative complications (bleeding, surgical infection etc.)	1 months

Collaborators and Investigators

• Sponsor: Bogomolets National Medical University
• Investigators: Study Director: Kateryna Bielka, PhD, Bogomolets National Medical University

Publications and helpful links

General Publications

• Schwendimann R, Blatter C, Luthy M, Mohr G, Girard T, Batzer S, Davis E, Hoffmann H. Adherence to the WHO surgical safety checklist: an observational study in a Swiss academic center. Patient Saf Surg. 2019 Mar 12;13:14. doi: 10.1186/s13037-019-0194-4. eCollection 2019.
• Sendlhofer G, Mosbacher N, Karina L, Kober B, Jantscher L, Berghold A, Pregartner G, Brunner G, Kamolz LP. Implementation of a surgical safety checklist: interventions to optimize the process and hints to increase compliance. PLoS One. 2015 Feb 6;10(2):e0116926. doi: 10.1371/journal.pone.0116926. eCollection 2015. Erratum In: PLoS One. 2015;10(4):e0123726.
• Bergs J, Hellings J, Cleemput I, Zurel O, De Troyer V, Van Hiel M, Demeere JL, Claeys D, Vandijck D. Systematic review and meta-analysis of the effect of the World Health Organization surgical safety checklist on postoperative complications. Br J Surg. 2014 Feb;101(3):150-8. doi: 10.1002/bjs.9381.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: GF230548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No