Airway Complication of AnesthesiaPAPAYA-IIINCT06117176
Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III
An observational study of Airway Complication of Anesthesia and Adverse Events, run by Insel Gruppe AG, University Hospital Bern at 5 sites in 2 countries.
Trial summary
The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Airway Complication of Anesthesia, Adverse Events
- How many people
- 40,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Feb 2025to Mar 2027
- How long will I take part?
- 30 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients (<18 years of age) that undergo in-hospital airway management under anaesthesia care who do not object to the use of their data collected for the purpose of this study.
Who may be able to join
- All adult patients requiring airway management under anaesthesia care for elective, semi-elective, urgent or emergency diagnostic procedures or interventions. Airway management includes awake and asleep tracheal intubation, insertion of supraglottic airway devices, and face mask ventilation.
- Patients older than 18 years of age
- Informed consent given or general consent in place, according to local ethics committee requirements.
Who cannot join
- Refusal to give consent or withdrawal of consent.
- Patients <18 years.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Switzerland3 sites, 3 recruiting
- Not yet recruiting
Kantonsspital Aarau
Aarau, 5001
Lorenz Theiler, Prof
- Recruiting
Inselspital, Bern University Hospital
Bern, Canton of Bern, 3010
Alexander Fuchs, MD, PD Dr. med., +41 31 632 23 84
- Not yet recruiting
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Patrick Schoettker, Prof
Germany2 sites, 2 recruiting
- Not yet recruiting
Deutsches Herzzentrum der Charité and Charité
Berlin, 13353
Maren Kleine-Bruggeney, Prof
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Martina Petzoldt, PD
About this study
Official title: Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care (PAPAYA III) - A European Multicentre Cross-sectional Observational Study
The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.
Read the detailed description
It is a prospective observational cross-sectional European multi-centre study collecting health-related patient data on anaesthetic airway management over three months. This detects the incidence and nature of local airway management problems and assesses how they are solved. This will enable the investigators to identify generalisable interventions and recommendations to further improve patients' airway management to improve patient safety. During the observational period, the anaesthesia staff in charge will fill out a screening questionnaire for airway management for every patient undergoing anaesthesia care with airway management. The investigators will extract the characteristics from the local anaesthesia record system for all patients. If no event arises, there are no further requirements. If an event occurs, the anaesthesia provider will fill out an additional form asking for more details on what happened.
- Conditions
- Airway Complication of Anesthesia, Adverse Events
- Keywords
- Intubation, Intratracheal, Anesthesiology, Difficult Airway, Critical events
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of airway management related incidents
Primary study outcome is the number of anaesthesia cases with at least one airway management related incidents in adult patients under anaesthesia care.
Measured: 30 days
Secondary outcomes (2)
The Incidences of the individual major incidents
Secondary study outcome parameters are the incidences of the major critical events and the number of incidents per case incidents.
Measured: 30 days
The Incidences of the individual minor incidents
Secondary study outcome parameters are the incidences of the minor critical events and the number of incidents per case incidents.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway Complication of AnesthesiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- 40,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, University of Lausanne Hospitals, Kantonsspital Aarau, Charite University, Berlin, Germany, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Robert Greif, MD, Prof, Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06117176
- Sponsor's protocol ID
- PAPAYA III
- Other IDs
- 2023-01752, 2023
- Acronym
- PAPAYA-III
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care (PAPAYA III) - A European Multicentre Cross-sectional Observational Study
- ClinicalTrials.gov ID
- NCT06117176
- Acronym / sponsor ID
- PAPAYA-III / PAPAYA III
- Conditions
- Airway Complication of Anesthesia, Adverse Events
- Keywords
- Intubation, Intratracheal, Anesthesiology, Difficult Airway, Critical events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, University of Lausanne Hospitals, Kantonsspital Aarau, Charite University, Berlin, Germany, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Nov 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.
The overall objective of the study is to evaluate and analyze major and minor incidents during airway management in adults under anaesthesia care at all study sites. The patient characteristics, type of airway management is recorded and if airway management-related incidents occur, they are analyzed in more detail to improve patient safety in the future.
Detailed description
It is a prospective observational cross-sectional European multi-centre study collecting health-related patient data on anaesthetic airway management over three months. This detects the incidence and nature of local airway management problems and assesses how they are solved. This will enable the investigators to identify generalisable interventions and recommendations to further improve patients' airway management to improve patient safety. During the observational period, the anaesthesia staff in charge will fill out a screening questionnaire for airway management for every patient undergoing anaesthesia care with airway management. The investigators will extract the characteristics from the local anaesthesia record system for all patients. If no event arises, there are no further requirements. If an event occurs, the anaesthesia provider will fill out an additional form asking for more details on what happened.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (<18 years of age) that undergo in-hospital airway management under anaesthesia care who do not object to the use of their data collected for the purpose of this study.
Key inclusion criteria (3 listed)
- All adult patients requiring airway management under anaesthesia care for elective, semi-elective, urgent or emergency diagnostic procedures or interventions. Airway management includes awake and asleep tracheal intubation, insertion of supraglottic airway devices, and face mask ventilation.
- Patients older than 18 years of age
- Informed consent given or general consent in place, according to local ethics committee requirements.
Key exclusion criteria (2 listed)
- Refusal to give consent or withdrawal of consent.
- Patients <18 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of airway management related incidents
Time frame: 30 days
Primary study outcome is the number of anaesthesia cases with at least one airway management related incidents in adult patients under anaesthesia care.
2 secondary outcomes
The Incidences of the individual major incidents
Time frame: 30 days
The Incidences of the individual minor incidents
Time frame: 30 days
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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Robert Greif, MD, Prof study chair
Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Airway Complication of Anesthesia and Adverse Events, run by Insel Gruppe AG, University Hospital Bern at 5 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 3 inclusion and 2 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland, Germany. 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 Thomas Riva, MD,PD (+41 31 632 21 11, thomas.riva@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of airway management related incidents (time frame: 30 days). 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 4 Mar 2026.