Effect of WHO Surgical Safety Checklist and Anesthesia Equipment Checklist on Patients Outcomes in Low-resource Settings.
1 other identifier
observational
2,200
1 country
1
Brief Summary
The study to investigate the effectiveness and the current perception of safety checklists in Ukrainian hospitals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedApril 4, 2023
March 1, 2023
11 months
March 22, 2023
March 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Postoperative complications
1 months
Study Arms (2)
Control
The control group without WHO and equipment checklist used
Study
Other group, where WHO safety check-list and equipment check-list were implemented
Eligibility Criteria
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.
You may qualify if:
- medical institutions with surgical departments
You may not qualify if:
- medical institutions without surgical departments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bogomolets NMU
Kyiv, Ukraine
Related Publications (3)
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.
PMID: 30918531BACKGROUNDSendlhofer 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.
PMID: 25658317BACKGROUNDBergs 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.
PMID: 24469615BACKGROUND
Study Officials
- STUDY DIRECTOR
Kateryna Bielka, PhD
Bogomolets National Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor at the Department of OF SURGERY, ANESTHESIOLOGY AND INTENSIVE THERAPY OF POSTGRADUATE EDUCATION
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 4, 2023
Study Start
February 1, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 4, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share