Perioperative Patient SafetyCIBOSurgNCT05818332
ClassIntra® for Better Outcomes in Surgery - CIBOSurg
An observational study of Perioperative Patient Safety, run by University Hospital, Basel, Switzerland at 10 sites in 2 countries.
Trial summary
Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Perioperative Patient Safety
- What is being tested?
- Observational study
- How many people
- 1,800 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 17 Jul 2023to Jul 2027
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement
Who may be able to join
- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement
Who cannot join
- Patients undergoing one-day-surgery (with or without anaesthesia-involvement)
- Procedures without anaesthesia-involvement (in- or out-patient)
- ASA risk classification (ASA) VI patients (brain-death, organ-donor)
- Follow-up procedure of a patient already included in the study
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Switzerland9 sites, 8 recruiting
- Completed
University Hospital Basel
Basel
- Recruiting
Lindenhofspital
Bern
Judith Winkens, +41 31 366 39 89, judith.winkens@lindenhofgruppe.ch
- Recruiting
University Hospital Berne
Bern
Andreas Vogt, Prof. Dr. med., +41 31 632 42 17, andreas.vogt@insel.ch
- Recruiting
Cantonal Hospital Graubünden
Chur
Gianluca Ursprung, Dipl. med., +41 81 256 69 32, gianluca.ursprung@ksgr.ch
- Recruiting
University Hospital Geneva
Geneva
Guy Haller, Prof. Dr. med., guy.haller@huge.ch
- Recruiting
University Hospital Lausanne
Lausanne
Dieter Hahnloser, Prof. Dr. med., +41 21 314 66 31, dieter.hahnloser@chuv.ch
- Recruiting
Cantonal Hospital Lucerne
Lucerne
Markus Gass, Dr. med., +41 41 205 45 39, markus.gass@luks.ch
- Recruiting
Regional Hospital Lugano
Lugano
Giorgio Prouse, Dr. med., +41 91 811 66 03, Giorgio.Prouse@eoc.ch
- Recruiting
University Hospital Zurich
Zurich
Valentin Neuhaus, Prof. Dr. med., +41 44 255 23 99, valentin.neuhaus@usz.ch
About this study
Official title: Implementation of Routine Recording of Intraoperative Adverse Events According to ClassIntra® During the Sign-out Phase of the WHO Surgical Safety Checklist Using a Multifaceted, Tailored Implementation Strategy: Protocol of a Collaborative Before- and After-cohort Project
Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued.
- Conditions
- Perioperative Patient Safety
- Being tested
- Observational study
- Keywords
- Perioperative safety, sign-out, intraoperative adverse events, ClassIntra®, hybrid design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention, observational only
| Study group | Role | What they receive |
|---|---|---|
| before and after implementation cohort | consecutive cohort of 900 surgical patients (baseline)
consecutive cohort of 900 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs) Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention fidelity - component checklist completion
Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.
Measured: 2 months after the end of the implementation
Secondary outcomes (7)
Intervention fidelity - component quality of checklist performance
Quality of the sign-out will be measured with the WHO behaviourally anchored rating scale (WHOBARS):
Quality will be measured in a random sample of 20-25%, assessed in those centres with well-established sign-out in the baseline period and in all centres in the after-implementation phase.
Measured: Up to four months after the implementation
Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps
Quantitative and qualitative evaluation of critical implementation steps followed or not (and why not) by each site, according to the proposed/designed implementation plan (template)
Measured: Up to four months after the implementation
Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory
Acceptability is the extent of perception among stakeholders that the intervention is agreeable or satisfactory. It will be measured according to the Acceptability of Intervention Measure (AIM).
Measured: Measured after the implementation
Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted
Adaptation is the extent to which sign-out and documentation of iAEs have been locally adapted. It will be measured by comparing the local checklists with the minimum standard sign-out.
Measured: Checklist and process modifications classified according to FRAME.
Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting
Appropriateness is the extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting. It will be measured by the Intervention Appropriateness Measure (IAM).
Measured: Measured after the implementation
Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting
Feasibility is the extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting. It will be measured by the Feasibility of Intervention Measure FIM.
Measured: Measured after the implementation
Sustainment
Sustainment is measured by comparing (full) adherence (defined as completeness of all ticks on the sign-out checklist) 12 months after implementation
Measured: 12 months after the last patient out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start17 Jul 2023
- Primary completionDec 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Patient SafetyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818332
- Sponsor's protocol ID
- Req-2023-00330
- Acronym
- CIBOSurg
- Status last verified
- Feb 2025
- First submitted
- 15 Mar 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Routine Recording of Intraoperative Adverse Events According to ClassIntra® During the Sign-out Phase of the WHO Surgical Safety Checklist Using a Multifaceted, Tailored Implementation Strategy: Protocol of a Collaborative Before- and After-cohort Project
- ClinicalTrials.gov ID
- NCT05818332
- Acronym / sponsor ID
- CIBOSurg / Req-2023-00330
- Conditions
- Perioperative Patient Safety
- Keywords
- Perioperative safety, sign-out, intraoperative adverse events, ClassIntra®, hybrid design
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 18 Apr 2023 (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.
Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| before and after implementation cohort | – | Other: Observational studyconsecutive cohort of 900 surgical patients (baseline) consecutive cohort of 900 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All in-hospital patients (consecutive) undergoing surgery in the operating room with anaesthesia involvement
Key inclusion criteria (1 listed)
- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement
Key exclusion criteria (4 listed)
- Patients undergoing one-day-surgery (with or without anaesthesia-involvement)
- Procedures without anaesthesia-involvement (in- or out-patient)
- ASA risk classification (ASA) VI patients (brain-death, organ-donor)
- Follow-up procedure of a patient already included in the study
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 |
|---|---|---|
| Observational studyNo intervention, observational only | Other | before and after implementation cohort |
Primary outcome
Intervention fidelity - component checklist completion
Time frame: 2 months after the end of the implementation
Checklist completion is defined as completeness of all ticks on the sign-out checklist taking into consideration the minimum standard.
7 secondary outcomes
Intervention fidelity - component quality of checklist performance
Time frame: Up to four months after the implementation
Implementation fidelity - Quantitative and qualitative evaluation of critical implementation steps
Time frame: Up to four months after the implementation
Intervention acceptability - extent of perception among stakeholders that the intervention is agreeable or satisfactory
Time frame: Measured after the implementation
Adaptation - extent to which sign-out and documentation of iAEs have been locally adapted
Time frame: Checklist and process modifications classified according to FRAME.
Appropriateness - extent to which staff perceive the intervention as being a good fit, relevant and compatible with their setting
Time frame: Measured after the implementation
Feasibility - extent to which sign-out and documentation of iAEs can be successfully used or carried out within a given setting
Time frame: Measured after the implementation
Sustainment
Time frame: 12 months after the last patient out
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Patient Safety, run by University Hospital, Basel, Switzerland at 10 sites in 2 countries.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Switzerland, Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salome Dell-Kuster, Prof. Dr. med. (+41 61 328 64 74, salome.dell-kuster@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention fidelity - component checklist completion (time frame: 2 months after the end of the implementation). 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 11 Feb 2025; AzTrials last refreshed its copy on 5 Nov 2026.