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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05798000
• Other study ID #: GF230548
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• medical institutions with surgical departments

Exclusion Criteria:

• medical institutions without surgical departments

Related Conditions & MeSH terms

• Safety Issues

Locations

Country	Name	City	State
Ukraine	Bogomolets NMU	Kyiv

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Country where clinical trial is conducted

Ukraine, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recorded critical incidents during the procedure	Recorded critical incidents during the procedure (hypotension, hypertension etc.)	24 hours
Primary	Mortality	Postoperative mortality during 28 days after surgery	28 days
Secondary	Postoperative complications	Postoperative complications (bleeding, surgical infection etc.)	1 months