Operating Room WHO Surgical Safety Checklist Process Completion: an Observational Study

NCT04965285 | Completed

• 1 other identifier: 2589
• Study Type: observational
• Target: 322
• Locations: 1 country
• Sites: 1

Brief Summary

The WHO Surgical Safety Checklist is a simple tool designed to improve the safety of surgical procedures by bringing together the whole operating team (surgeons, anaesthesia providers and nurses) to perform key safety checks during vital phases of perioperative care: prior to the induction of anesthesia, prior to skin incision and before the team leaves the operating room. In 2007, WHO Patient Safety launched the Second Global Patient Safety Challenge, Safe Surgery Saves Lives.Anaesthetists, operating theatre nurses, surgeons, safety experts, patients and other professionals came together and came up with the WHO Surgical Safety Checklist. The 19 items of the surgical checklist have shown to improve on mortality and morbidity. Surgical time out is carried out before the start of any surgical procedures to reduce the occurrence of wrong-site, wrong-procedure, and wrong-person surgery where the patient's identity, the procedure, and the surgical site before surgical incision or the start of the procedure is verified. This also helps to raise any concern regarding the procedural risk and any concerns, prevent medical errors, patient morbidity, patient mortality, and reduce surgical complication rates. The Checklist is intended as a tool for use by clinicians interested in improving the safety of their operations and reducing unnecessary surgical deaths and complications and also help ensure that teams consistently follow a few critical safety steps and thereby minimize the most common and avoidable risks endangering the lives and wellbeing of surgical patients . The aim of this Checklist is to reinforce accepted safety practices and foster better communication and teamwork between clinical disciplines.

Conditions

Safety Issues; Patient Acceptance of Health Care

Keywords

Time Out, Healthcare

Outcome Measures

Primary Outcomes (1)

• Quality of execution of the WHO surgical safety checklist in routine clinical practice

  to evaluate for quality of execution of WHO surgical safety checklist during routine practice before every surgical procedures in our institute.

  1 day

Secondary Outcomes (1)

• To evaluate for any distractions and interruptions, deviations from protocol, and the problem-solving strategies used by operating room team members to mitigate the non routine events

  1 day

Interventions

quality assesment BEHAVIORAL

For each time-out procedure observed, the investigators will record compliance for each element of the time-out. Elements that are clearly verbalized by the member of the operating room team performing the time-out were considered compliant. As each step of the time-out is verbalized by a team member, the operating room team members are expected to respond. The observations will be conducted by trained study staff using a standardized Checklist/ Proforma to assess surgical team compliance with the time-out protocol and to record general observations of the operating room environment. Any non-routine events that occurred during the time-out process will be recorded. In each phase, the Checklist coordinator must be permitted to confirm that the team has completed its tasks before it proceeds onward.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all surgical cases for elective surgeries, aged 18 and above, will be included on this study

You may qualify if:

• Age above 18 years surgical patients undergoing surgery at Nepal Mediciti Hospital

You may not qualify if:

• Emergency surgical cases, patients not being able to participate verbally

Sponsors & Collaborators

• Nepal Mediciti Hospital: lead

Study Sites (1)

Nepal mediciti Hospital

Kathmandu, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• bikash khadka, MD

  Nepal Mediciti Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 16, 2021
• Study Start: August 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: October 28, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Actual Study Start Date: May 2021 Estimated Primary Completion Date: January 2022 Estimated Study Completion Date: February 2022
• Access Criteria: On contact via Email services, description will be made available

Locations

NE (1)