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Recruiting NCT06117176

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

Observational Airway Complication of Anesthesia Adverse Events

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Airway Complication of Anesthesia, Adverse Events. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Prospective Assessment Project of AirwaY Management-related Incidents in Adult Anaesthesia Care (PAPAYA III) - A European Multicentre Cross-sectional Observational Study

Overview

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.

Primary outcome measures

  • Number of airway management related incidents [Time frame: 30 days]
Secondary outcome measures (2)
  • The Incidences of the individual major incidents [Time frame: 30 days]
  • The Incidences of the individual minor incidents [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 3 centers
  • Inselspital, Bern University Hospital — Bern
  • Kantonsspital Aarau — Aarau
  • CHUV Centre Hospitalier Universitaire Vaudois — Lausanne
Germany · 2 centers
  • Deutsches Herzzentrum der Charité and Charité — Berlin
  • Universitätsklinikum Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT06117176 · PAPAYA III · 2023-01752

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗