Airway ComplicationsPapayaNCT02743767
Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations
A study testing Introducing five different treating adaptations in people with Airway Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Complications
- What is being tested?
- Introducing five different treating adaptations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,455 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must receive a general anaesthesia with any form of airway management
Who cannot join
- Anaesthesia without airway management
- Patients who do not give or who withdraw general consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Airway Complications
- Being tested
- Introducing five different treating adaptations
- Keywords
- Airway management, General anaesthesia, Critical incidents, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introducing five different treating adaptationsProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Before interventions | No intervention | Only observational activity for this arm, to record the frequency and triggering factors of airway complications during general anaesthesia. |
| After interventions | Experimental | After introducing five different treating adaptations in airway management we want to record the frequency of airway complications during general anaesthesia. Receives: Procedure: Introducing five different treating adaptations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of airway complications after introducing five treatment adaptations
Measured: 2 months
Secondary outcomes (2)
Postoperative side effects after routinely general anaesthesia
Measured: 2 months
Frequency of reporting critical incident (CIRS)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Airway ComplicationsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Greif, MD MME FERC, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743767
- Sponsor's protocol ID
- PAPAYA
- Acronym
- Papaya
- Status last verified
- Nov 2016
- First submitted
- 5 Apr 2016
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Huber M, Greif R, Pedersen TH, Theiler L, Kleine-Brueggeney M. Risk patterns of consecutive adverse events in airway management: a Bayesian network analysis. Br J Anaesth. 2023 Mar;130(3):368-378. doi: 10.1016/j.bja.2022.11.007. Epub 2022 Dec 22.
PubMed 36564247Pedersen TH, Ueltschi F, Hornshaw T, Greif R, Theiler L, Huber M, Kleine-Brueggeney M. Optimisation of airway management strategies: a prospective before-and-after study on events related to airway management. Br J Anaesth. 2021 Nov;127(5):798-806. doi: 10.1016/j.bja.2021.07.030. Epub 2021 Sep 15.
PubMed 34535275
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Airway Complications During General Anaesthesia After Introducing Five Handling Adaptations
- ClinicalTrials.gov ID
- NCT02743767
- Acronym / sponsor ID
- Papaya / PAPAYA
- Conditions
- Airway Complications
- Keywords
- Airway management, General anaesthesia, Critical incidents, Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,455 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before interventions | No intervention | –Only observational activity for this arm, to record the frequency and triggering factors of airway complications during general anaesthesia. |
| After interventions | Experimental | Procedure: Introducing five different treating adaptationsAfter introducing five different treating adaptations in airway management we want to record the frequency of airway complications during general anaesthesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must receive a general anaesthesia with any form of airway management
Key exclusion criteria (2 listed)
- Anaesthesia without airway management
- Patients who do not give or who withdraw general consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introducing five different treating adaptationsImmediate 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. | Procedure or surgery | After interventions |
Primary outcome
Reduction of airway complications after introducing five treatment adaptations
Time frame: 2 months
2 secondary outcomes
Postoperative side effects after routinely general anaesthesia
Time frame: 2 months
Frequency of reporting critical incident (CIRS)
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Derived from this study: PubMed 36564247Huber M, Greif R, Pedersen TH, Theiler L, Kleine-Brueggeney M. Risk patterns of consecutive adverse events in airway management: a Bayesian network analysis. Br J Anaesth. 2023 Mar;130(3):368-378. doi: 10.1016/j.bja.2022.11.007. Epub 2022 Dec 22.
- Derived from this study: PubMed 34535275Pedersen TH, Ueltschi F, Hornshaw T, Greif R, Theiler L, Huber M, Kleine-Brueggeney M. Optimisation of airway management strategies: a prospective before-and-after study on events related to airway management. Br J Anaesth. 2021 Nov;127(5):798-806. doi: 10.1016/j.bja.2021.07.030. Epub 2021 Sep 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Greif, MD MME FERC study chair
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introducing five different treating adaptations in people with Airway Complications, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of airway complications after introducing five treatment adaptations (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743767, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.