Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III (PAPAYA-III)

March 2, 2026 updated by: Insel Gruppe AG, University Hospital Bern

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Not yet recruiting
        • Deutsches Herzzentrum der Charité and Charité
        • Contact:
          • Maren Kleine-Bruggeney, Prof
      • Hamburg, Germany, 20246
        • Not yet recruiting
        • Universitätsklinikum Hamburg-Eppendorf
        • Contact:
          • Martina Petzoldt, PD
  • Switzerland
      • Aarau, Switzerland, 5001
        • Not yet recruiting
        • Kantonsspital Aarau
        • Contact:
          • Lorenz Theiler, Prof
      • Lausanne, Switzerland, 1011
        • Not yet recruiting
        • CHUV Centre Hospitalier Universitaire Vaudois
        • Contact:
          • Patrick Schoettker, Prof
    • Canton of Bern
      • Bern, Canton of Bern, Switzerland, 3010
        • Recruiting
        • Inselspital, Bern University Hospital
        • Contact:
          • Alexander Fuchs, MD, PD Dr. med.
          • Phone Number: +41 31 632 23 84

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Refusal to give consent or withdrawal of consent.
  • Patients <18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Incidences of the individual major incidents
Time Frame: 30 days
Secondary study outcome parameters are the incidences of the major critical events and the number of incidents per case incidents.
30 days
The Incidences of the individual minor incidents
Time Frame: 30 days
Secondary study outcome parameters are the incidences of the minor critical events and the number of incidents per case incidents.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Insel Gruppe AG, University Hospital Bern

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Charite University, Berlin, Germany
Kantonsspital Aarau
University of Lausanne Hospitals
University of Bern
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Robert Greif, MD, Prof, Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAPAYA III
  • 2023-01752 (Registry Identifier: Swissethics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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