Safety IssuesNCT04965285
Operating Room WHO Surgical Safety Checklist Process Completion: an Observational Study
An observational study of Safety Issues and Patient Acceptance of Health Care, run by Nepal Mediciti Hospital at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Patient Acceptance of Health Care
- What is being tested?
- quality assesment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 322 participants
- Where
- 1 siteNepal
- Study dates
- 1 Aug 2021to 28 Oct 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all surgical cases for elective surgeries, aged 18 and above, will be included on this study
Who may be able to join
- Age above 18 years surgical patients undergoing surgery at Nepal Mediciti Hospital
Who cannot join
- Emergency surgical cases, patients not being able to participate verbally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Safety Issues, Patient Acceptance of Health Care
- Being tested
- quality assesment
- Keywords
- Time Out, Healthcare
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality assesmentBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Aug 2021
- Primary completion1 Oct 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 322 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nepal Mediciti Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bikash Khadka, Nepal Mediciti Hospital
- Investigators
- bikash khadka, MD, Principal investigator, Nepal Mediciti Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965285
- Sponsor's protocol ID
- 2589
- Status last verified
- Oct 2023
- First submitted
- 30 Jun 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: research data will be made available if requested or contacted via Email services
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operating Surgical Checklist Completion Out Before Surgical Procedures
- ClinicalTrials.gov ID
- NCT04965285
- Acronym / sponsor ID
- 2589
- Conditions
- Safety Issues, Patient Acceptance of Health Care
- Keywords
- Time Out, Healthcare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Nepal Mediciti HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all surgical cases for elective surgeries, aged 18 and above, will be included on this study
Key inclusion criteria (1 listed)
- Age above 18 years surgical patients undergoing surgery at Nepal Mediciti Hospital
Key exclusion criteria (1 listed)
- Emergency surgical cases, patients not being able to participate verbally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality assesmentFor 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. | Behavioural | – |
Primary outcome
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: Yes. research data will be made available if requested or contacted via Email services
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bikash khadka, MD principal investigator
Nepal Mediciti Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Safety Issues and Patient Acceptance of Health Care, run by Nepal Mediciti Hospital at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of execution of the WHO surgical safety checklist in routine clinical practice (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.