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

Not yet recruiting

• Conditions: Adverse Events; Airway Complication of Anesthesia

• Registration Number: NCT06117176
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study First Posted: 2023-11-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Study Start: 2025-01
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of airway management related incidents	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.

Secondary Outcome Measures

Name	Time	Method
The Incidences of the individual minor incidents	30 days	Secondary study outcome parameters are the incidences of the minor critical events and the number of incidents per case incidents.
The Incidences of the individual major incidents	30 days	Secondary study outcome parameters are the incidences of the major critical events and the number of incidents per case incidents.

Trial Locations

Locations (4)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Deutsches Herzzentrum der Charité and Charité; 🇩🇪 Berlin, Germany

CHUV Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland