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Completed

NCT Number: NCT05798000

Effect of WHO Surgical Safety Checklist and Anesthesia 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.

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bogomolets NMU

Kyiv, Ukraine

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • medical institutions with surgical departments

Exclusion criteria

  • medical institutions without surgical departments

Treatment and study plan

Primary outcomes

  1. Recorded critical incidents during the procedure

    Time frame: 24 hours

    Recorded critical incidents during the procedure (hypotension, hypertension etc.)

  2. Mortality

    Time frame: 28 days

    Postoperative mortality during 28 days after surgery

Secondary outcomes

  1. Postoperative complications

    Time frame: 1 months

    Postoperative complications (bleeding, surgical infection etc.)

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2023
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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