The Danish Anaesthesia Database and the Prediction of DIFFICult AIRway Management Trial: "The DIFFICAIR-Trial"

This study is currently recruiting participants.
Verified October 2012 by Hillerod Hospital, Denmark
Sponsor:
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
TrygFonden, Denmark
Information provided by (Responsible Party):
Anders Nørskov, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT01718561
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

In general anesthetic the patient is deprived of his awareness and ability to breathe. It is therefore one of the most important tasks in anesthesia to ensure the patient's airway and breathing. It has been shown both in Denmark and internationally that failed management of the patient's airway is the main anesthesia-related cause of death and brain damage. Therefore, it is very important and highly prioritized among anesthesia personal, to be able to identify patients with a difficult airway. The aim of "The DIFFICAIR Trial" is to reduce the incidence of UNEXPECTED difficult airway management by optimizing assessment of the patient's airway before anesthesia. There is an international consensus on the importance of proper identification of patients with a difficult airway prior to anesthesia. Enabling optimal preparation and thus reducing mortality and complications. The DIFFICAIR Trial is a nationwide multicentre trial with approx. 70,000 patients. 28 of the country's anesthesia departments is randomized either to airway assessment based on the physicians' clinical judgment (current practice) or to use an objective riskscore for airway evaluations including anatomical conditions known to be associated with difficult airway management. Data from The Danish Anesthesia Database is used to compare the success rates of the two methods. We hope that by using a systematic airway assessment we may reduce the number of unexpected difficult airway managements and thereby reducing the associated complications and death. Based on data we will contribute to a national recommendation for airway assessment before anesthesia.


Condition Intervention
Airway Management
Intubation, Intratracheal
Procedure: SARI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of a Systematically Registered, Objective Airway Assessment Versus Conventional Clinical Assessment on the Prevalence of Unexpected Difficult Airway Management - A Cluster-randomized Clinical Trial on 28 Anaesthesia Departments With 70,000 Patients Registered in the Danish Anaesthesia Database

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • number of unexpected difficult intubation [False-negative] / number of all primary (attempted) intubated by direct laryngoscopy [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will also be assessed for mask ventilation instead of intubation (cohort 3)

  • number of expected difficult intubations (or mask ventilations) which is actually unproblematic [False Positive] / number of all primary (attempted) intubated by direct laryngoscopy (or mask ventilated) [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will also be assessed for mask ventilation instead of intubation (cohort 3)

  • (number of unexpected difficult intubations [False-negative] + number of intubations, which is expected difficult and subsequently planned for and intubated by an advanced method) / number of all (attempted) intubated [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 48 hour mortality [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcom measure will be assessed for all three cohorts

  • 30-day mortality [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcom measure will be assessed for all three cohorts

  • unexpected difficult intubation [False Negative] / actual difficult intubation ([False-negative] + [True Positive]). [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will also be assessed for mask ventilation instead of intubation (cohort 3)

  • Sensitivity: [True Positive] / ([Sand Positive] + [False Negative]). [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will be assessed for all three cohorts

  • Specificity: [True Negative] / ([True Negative] + [False Positive]) [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will be assessed for all three cohorts

  • Positive Predictive Value: [True Positive] / ([Sand Positive] + [False Positive]) [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will be assessed for all three cohorts

  • Negative predictive value: [True Negative] / ([True Negative] + [False Negative]) [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will be assessed for all three cohorts

  • Positive Likelihood Ratio = (Sensitivity / (1-specificity)) [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]
    This outcome measure will be assessed for all three cohorts

  • ROC curve [ Time Frame: From October 2012 to October 2013 ] [ Designated as safety issue: Yes ]

    "The receiver operating characteristic" curve. Graphical representation of the sensitivity as a function of (1-specificity). Suitable for comparison of predictive models.

    This outcome measure will be assessed for all three cohorts



Estimated Enrollment: 70000
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual clinical airway evaluation and usual registration in Danish Anaesthesia Database (without SARI registration)
Experimental: SARI
Registration of Modified SARI score and predictors for difficult mask ventilation in Danish Anaesthesia Database
Procedure: SARI
The use of Modified Simplified Airway Risk Index (SARI) as preoperative airway assessment and assessment of riskfactor for difficult mask ventilation. Registration in Danish Anesthesia Database

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Cohort 1:

Patients with a pre-operative airway plan of either

  • Non / unknown
  • Spontaneous respiration
  • Mask Ventilation
  • Laryngeal Mask etc.. (any kind)
  • Intubation by direct laryngoscopy

and primarily (attempted) intubated by direct laryngoscopy

Cohort 2:

All patients in cohort 1, and patients with an airway plan of either

  • Intubation with video laryngoscope
  • Intubation with flexible fiberoptic scope
  • Intubation by another method (Fastrach, Trachlight, etc.).

which was expected difficult to intubate by direct laryngoscopy

Cohort 3:

All patients who are mask ventilated.

Exclusion Criteria:

  • Children under 15 years
  • Patients who can not co-operate for the examination (unconscious, demented, severely traumatized, etc..)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718561

Contacts
Contact: Anders K Nørskov, MD +45 40103387 anderskehlet@hotmail.com

Locations
Denmark
Department of anesthesia, Hillerød Hospital Recruiting
Hillerød, Region Hovedstaden, Denmark, 3400
Contact: Anders K Nørskov, MD     + 45 40103387     anderskehlet@hotmail.com    
Contact: Lars H Lundstrøm, Phd, MD     +45 26852525     lars_hyldborg@hotmail.com    
Principal Investigator: Anders K Nørskov, MD            
Abdominalcentret Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Juliane Marie centret Rigshospitalet Recruiting
Copenhagen, Denmark
Hovedorto centret Rigshospitalet Recruiting
Copenhagen, Denmark
Bispebjerg hospital Recruiting
Copenhagen, Denmark
Neurocentret Rigshospitalet Recruiting
Copenhagen, Denmark
thoraxcentret Rigshospitalet Recruiting
Copenhagen, Denmark
Aleris-Hamlet Recruiting
Esbjerg, Denmark
Frederiksberg hospital Recruiting
Frederiksberg, Denmark
Glostrup Hospital Recruiting
Glostrup, Denmark
Haderslev Hospital Recruiting
Haderslev, Denmark
Bekkevold klinikken Recruiting
Hellerup, Denmark
Herlev Hospital Recruiting
Herlev, Denmark
Aleris-Hamlet Recruiting
Herning, Denmark
Kolding sygehus Recruiting
Kolding, Denmark
Kollund privathospital Recruiting
Kollund, Denmark
Københavnsprivathospital Recruiting
Lyngby, Denmark
Nykøbing falster sygehus Recruiting
Nykøbing Falster, Denmark
Næstved Hospital Recruiting
Næstved, Denmark
Roskilde Sygehus Recruiting
Roskilde, Denmark
Bornholm sygehus Recruiting
Rønne, Denmark
Aleris-Hamlet Recruiting
Søborg, Denmark
Sønder sygehus Recruiting
Sønderborg, Denmark
Thisted sygehus Recruiting
Thisted, Denmark
Vejle Sygehus Recruiting
Vejle, Denmark
Åbenrå sygehus Recruiting
Åbenrå, Denmark
Aleris-Hamlet Recruiting
Ålborg, Denmark
Aleris-Hamlet Recruiting
Århus, Denmark
Sponsors and Collaborators
Hillerod Hospital, Denmark
Copenhagen Trial Unit, Center for Clinical Intervention Research
TrygFonden, Denmark
Investigators
Principal Investigator: Anders K Nørskov, MD Hillerød Hospital
  More Information

No publications provided

Responsible Party: Anders Nørskov, MD, clinical assistant, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01718561     History of Changes
Other Study ID Numbers: DIFFICAIR
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Hillerod Hospital, Denmark:
Airway assessment
Intubation
Mask ventilation

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013