NCT02743767

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,455

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

April 5, 2016

Last Update Submit

November 9, 2016

Conditions

Airway Complications

Keywords

Airway managementGeneral anaesthesiaCritical incidentsComplications

Outcome Measures

Primary Outcomes (1)

  • Reduction of airway complications after introducing five treatment adaptations

    2 months

Secondary Outcomes (2)

  • Postoperative side effects after routinely general anaesthesia

    2 months

  • Frequency of reporting critical incident (CIRS)

    2 months

Study Arms (2)

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.

Procedure: Introducing five different treating adaptations

Interventions

Introducing five different treating adaptationsPROCEDURE

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.

After interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Anaesthesia without airway management
  • Patients who do not give or who withdraw general consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Bern, Canton of Bern, CH-3010, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 36564247DERIVED

  • Pedersen 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.

    PMID: 34535275DERIVED

Study Officials

  • Robert Greif, MD MME FERC

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2016

First Posted

April 19, 2016

Study Start

May 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

CH(1)