- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04965285
Operating Room WHO Surgical Safety Checklist Process Completion: an Observational Study
Operating Surgical Checklist Completion Out Before Surgical Procedures
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Definition of terms A time-out is defined as "an immediate pause by the entire surgical team to confirm the correct patient, procedure, and site," for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery for all accredited hospitals, ambulatory care centers, and office-based surgery facilities Elements that are clearly verbalized by the member of the operating room team performing the time-out were considered compliant Distraction is defined as any involvement in an activity concerning a non-life-threatening issue by any operating room team member, including conversations unrelated to the time-out, loud music playing, unexpected entrances, and personnel engaged in other tasks, among others.
The Checklist divides the operation into three phases, each corresponding to a specific time period in the normal flow of a procedure-the period before induction of anaesthesia, the period after induction and before surgical incision, and the period during or immediately after wound closure but before removing the patient from the operating room.
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.
Anticipated and actual blood loss, anticipated and actual surgical duration will also be noted
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Bikash Khadka, MD
- Phone Number: +9779841411827
- Email: khadka.vkas@gmail.com
Study Contact Backup
- Name: Apurb sharma, MD
Study Locations
-
-
Bagmati
-
Kathmandu, Bagmati, Nepal, 44600
- Nepal Mediciti Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age above 18 years surgical patients undergoing surgery at Nepal Mediciti Hospital
Exclusion Criteria:
- Emergency surgical cases, patients not being able to participate verbally
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of execution of the WHO surgical safety checklist in routine clinical practice
Time Frame: 1 day
|
to evaluate for quality of execution of WHO surgical safety checklist during routine practice before every surgical procedures in our institute.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 1 day
|
to check for any factors that distracts or disturbs during conductance of WHO surgical checklist. to evaluate if there has been any deviation from protocol to check for any non routine events and any measures taken to overcome them |
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: bikash khadka, MD, Nepal Mediciti Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2589
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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