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

NCT06117176 | Recruiting

• 2 other identifiers: PAPAYA III2023-01752
• Study Type: observational
• Target: 40,000
• Locations: 2 countries
• Sites: 5

Brief 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 improve patient safety in the future.

Conditions

Airway Complication of Anesthesia; Adverse Events

Keywords

Intubation, Intratracheal; Anesthesiology; Difficult Airway; Critical events

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (2)

• The Incidences of the individual major incidents

  30 days

• The Incidences of the individual minor incidents

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Bern: collaborator
• Insel Gruppe AG, University Hospital Bern: lead
• University of Lausanne Hospitals: collaborator
• Kantonsspital Aarau: collaborator
• Charite University, Berlin, Germany: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator

Study Sites (5)

Deutsches Herzzentrum der Charité and Charité

Berlin, 13353, Germany

NOT YET RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

NOT YET RECRUITING

Inselspital, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Kantonsspital Aarau

Aarau, 5001, Switzerland

NOT YET RECRUITING

CHUV Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

NOT YET RECRUITING

Study Officials

• Robert Greif, MD, Prof

  Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University

  STUDY CHAIR

Central Study Contacts

Thomas Riva, MD,PD

CONTACT

+41 31 632 21 11; thomas.riva@insel.ch

Alexander Fuchs, MD

CONTACT

+41 31 664 14 65; alexander.fuchs@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); CH (3)