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

NCT ID: NCT05798000

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2022-12-31

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).

Conditions

Safety Issues

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control

The control group without WHO and equipment checklist used

No interventions assigned to this group

Study

Other group, where WHO safety check-list and equipment check-list were implemented

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• medical institutions with surgical departments

Exclusion Criteria

• medical institutions without surgical departments

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bogomolets National Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kateryna Bielka

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kateryna Bielka, PhD

Role: STUDY_DIRECTOR

Bogomolets National Medical University

Locations

Bogomolets NMU

Kyiv, , Ukraine

Countries

Ukraine

References

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.

Reference Type: BACKGROUND

PMID: 30918531 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25658317 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24469615 (View on PubMed)

Other Identifiers

GF230548

Identifier Type: -

Identifier Source: org_study_id