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

November 9, 2016 updated by: University Hospital Inselspital, Berne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7455

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, CH-3010
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Before interventions
Only observational activity for this arm, to record the frequency and triggering factors of airway complications during general anaesthesia.
Experimental: After interventions
After introducing five different treating adaptations in airway management we want to record the frequency of airway complications during general anaesthesia.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of airway complications after introducing five treatment adaptations
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative side effects after routinely general anaesthesia
Time Frame: 2 months
2 months
Frequency of reporting critical incident (CIRS)
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Investigators

  • Study Chair: Robert Greif, MD MME FERC, University Hospital Inselspital, Berne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

April 5, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PAPAYA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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