Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations

Airway Complications Clinical Trial

— Papaya  

Official title:

Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02743767
• Other study ID #: PAPAYA
• Status: Completed
• Phase: N/A
• First received: April 5, 2016
• Last updated: November 9, 2016
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if five simple adaptations in airway management of patients undergoing general anaesthesia can reduce minor and major airway complications.

After a first detection of causes of airway complications during general anaesthesia investigators initiated five different interventions in airway management, which were: immediate bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate change of provider in case of failed intubation.

In a second phase of this observational study investigators want to evaluate if these five interventions can reduce minor and major airway complications during general anaesthesia.

Additionally, investigators want to record how many critical incidents (CIRS) occur during this observational period and how many of them will be reported by the involved stuff.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7455
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Must receive a general anaesthesia with any form of airway management

Exclusion Criteria:

• Anaesthesia without airway management

• Patients who do not give or who withdraw general consent

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Airway Complications

Intervention

Procedure:
• Introducing five different treating adaptations
Immediate Bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate hand alternately if frustrated intubation.

Locations

Country	Name	City	State
Switzerland	University Hospital	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of airway complications after introducing five treatment adaptations		2 months	Yes
Secondary	Postoperative side effects after routinely general anaesthesia		2 months	No
Secondary	Frequency of reporting critical incident (CIRS)		2 months	Yes