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

Airway Complication of Anesthesia Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117176
• Other study ID #: PAPAYA III
• Secondary ID: 2023-01752
• Status: Not yet recruiting
• Start date: January 2025
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Thomas Riva, MD,PD
• Phone: +41 31 632 21 11
• Email: thomas.riva[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 improve patient safety in the future.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40000
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Events
• Airway Complication of Anesthesia

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum der Charité and Charité	Berlin
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Switzerland	Kantonsspital Aarau	Aarau
Switzerland	CHUV Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (6)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern	Charite University, Berlin, Germany, Kantonsspital Aarau, Universitätsklinikum Hamburg-Eppendorf, University of Bern, University of Lausanne Hospitals

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	30 days
Secondary	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.	30 days