Clinical trial NCT06117176: Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care PAPAYA III
Official title: Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care (PAPAYA III) - A European Multicentre Cross-sectional Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Airway Complication of Anesthesia
Adverse Events
Keywords: Intubation, Intratracheal
Anesthesiology
Difficult Airway
Critical events
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
name: University of Lausanne Hospitals
name: Kantonsspital Aarau
name: Charite University, Berlin, Germany
name: Universitätsklinikum Hamburg-Eppendorf
First posted: 2023-11-03
Enrollment: 40000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of airway management related incidents
timeFrame: 30 days
Secondary outcomes:
measure: The Incidences of the individual major incidents
timeFrame: 30 days
measure: The Incidences of the individual minor incidents
timeFrame: 30 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité and Charité
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Lausanne
country: Switzerland
facility: CHUV Centre Hospitalier Universitaire Vaudois
Study officials:
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University
name: Robert Greif, MD, Prof
role: STUDY_CHAIR
References: