The Difficult Airway Management Trial: "The DIFFICAIR-Trial" (DIFFICAIR)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 risk score 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 or disease	Intervention/treatment	Phase
Airway Management; Intubation, Intratracheal	Procedure: SARI	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	76058 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Incidence of Unanticipated Difficult Airway Using an Objective Airway Score Versus a Standard Clinical Airway Assessment, The DIFFICAIR Trial - A Cluster-randomized Clinical Trial on 28 Anaesthesia Departments With 70,000 Patients Registered in the Danish Anaesthesia Database
Study Start Date :	October 2012
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	January 2014

Arms and Interventions

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Arm	Intervention/treatment
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 risk factor for difficult mask ventilation. Registration in Danish Anesthesia Database

Outcome Measures

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Primary Outcome Measures :

1. Fraction of unanticipated difficult intubations = intubations with unanticipated difficulties [False negative] / all patients primarily (attempted) intubated by direct laryngoscopy [ Time Frame: From October 2012 to December 2013 ]
   This outcome measure will also be assessed for mask ventilation instead of intubation
2. Fraction of unanticipated easy intubations = intubations with anticipated difficulties that were easy [False Positive] / all patients primarily (attempted) intubated by direct laryngoscopy [ Time Frame: From October 2012 to December 2013 ]
   This outcome measure will also be assessed for mask ventilation instead of intubation

Secondary Outcome Measures :

1. 48 hour mortality [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
2. 30-day mortality [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
3. unexpected difficult intubation [False Negative] / actual difficult intubation ([False-negative] + [True Positive]). [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will also be assessed for mask ventilation instead of intubation (cohort 3)
4. Sensitivity: [True Positive] / ([Sand Positive] + [False Negative]). [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
5. Specificity: [True Negative] / ([True Negative] + [False Positive]) [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
6. Positive Predictive Value: [True Positive] / ([Sand Positive] + [False Positive]) [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
7. Negative predictive value: [True Negative] / ([True Negative] + [False Negative]) [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
8. Positive Likelihood Ratio = (Sensitivity / (1-specificity)) [ Time Frame: From October 2012 to October 2013 ]
   This outcome measure will be assessed for all three cohorts
9. ROC curve [ Time Frame: From October 2012 to October 2013 ]

   "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

10. • Fraction = intubations anticipated to be difficult, thus planned for, and intubated by, an advanced method / all patients (attempted) intubated. [ Time Frame: October 2012 - December 2013 ]

Eligibility Criteria

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Ages Eligible for Study:	15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Cohort 1:

Patients with a preoperative 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 fiber optic 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

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Locations

Denmark
Department of anesthesia, Hillerød Hospital
Hillerød, Region Hovedstaden, Denmark, 3400
Abdominalcentret Rigshospitalet
Copenhagen, Denmark, 2100
Bispebjerg hospital
Copenhagen, Denmark
Hovedorto centret Rigshospitalet
Copenhagen, Denmark
Juliane Marie centret Rigshospitalet
Copenhagen, Denmark
Neurocentret Rigshospitalet
Copenhagen, Denmark
thoraxcentret Rigshospitalet
Copenhagen, Denmark
Aleris-Hamlet
Esbjerg, Denmark
Frederiksberg hospital
Frederiksberg, Denmark
Glostrup Hospital
Glostrup, Denmark
Haderslev Hospital
Haderslev, Denmark
Bekkevold klinikken
Hellerup, Denmark
Herlev Hospital
Herlev, Denmark
Aleris-Hamlet
Herning, Denmark
Kolding sygehus
Kolding, Denmark
Kollund privathospital
Kollund, Denmark
Københavnsprivathospital
Lyngby, Denmark
Nykøbing falster sygehus
Nykøbing Falster, Denmark
Næstved Hospital
Næstved, Denmark
Roskilde Sygehus
Roskilde, Denmark
Bornholm sygehus
Rønne, Denmark
Aleris-Hamlet
Søborg, Denmark
Sønder sygehus
Sønderborg, Denmark
Thisted sygehus
Thisted, Denmark
Vejle Sygehus
Vejle, Denmark
Åbenrå sygehus
Åbenrå, Denmark
Aleris-Hamlet
Ålborg, Denmark
Aleris-Hamlet
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	Hillerod Hospital, Denmark

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nørskov AK, Wetterslev J, Rosenstock CV, Afshari A, Astrup G, Jakobsen JC, Thomsen JL, Bøttger M, Ellekvist M, Schousboe BM, Horn A, Jørgensen BG, Lorentzen K, Madsen MH, Knudsen JS, Thisted BK, Estrup S, Mieritz HB, Klesse T, Martinussen HJ, Vedel AG, Maaløe R, Bøsling KB, Kirkegaard PR, Ibáñez CR, Aleksandraviciute G, Hansen LS, Mantoni T, Lundstrøm LH. Effects of using the simplified airway risk index vs usual airway assessment on unanticipated difficult tracheal intubation - a cluster randomized trial with 64,273 participants. Br J Anaesth. 2016 May;116(5):680-9. doi: 10.1093/bja/aew057.

Nørskov AK, Lundstrøm LH, Rosenstock CV, Wetterslev J. Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial. Trials. 2014 May 15;15:173. doi: 10.1186/1745-6215-15-173.

Nørskov AK, Rosenstock CV, Wetterslev J, Lundstrøm LH. Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial - trial protocol for a cluster randomized clinical trial. Trials. 2013 Oct 23;14:347. doi: 10.1186/1745-6215-14-347.

Responsible Party:	Anders Nørskov, MD, clinical assistant, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:	NCT01718561 History of Changes
Other Study ID Numbers:	DIFFICAIR
First Posted:	October 31, 2012
Last Update Posted:	February 10, 2014
Last Verified:	February 2014

Keywords provided by Anders Nørskov, Hillerod Hospital, Denmark:

Airway assessment; Intubation; Mask ventilation

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs