The Difficult Airway Management Trial: "The DIFFICAIR-Trial" (DIFFICAIR)
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ClinicalTrials.gov Identifier: NCT01718561 |
Recruitment Status
:
Completed
First Posted
: October 31, 2012
Last Update Posted
: February 10, 2014
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Condition or disease | Intervention/treatment | Phase |
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Airway Management Intubation, Intratracheal | Procedure: SARI | Not Applicable |

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 |

Arm | Intervention/treatment |
---|---|
No Intervention: Control
Usual clinical airway evaluation and usual registration in Danish Anaesthesia Database (without SARI registration)
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Experimental: SARI
Registration of Modified SARI score and predictors for difficult mask ventilation in Danish Anaesthesia Database
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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
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- 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
- 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
- 48 hour mortality [ Time Frame: From October 2012 to October 2013 ]This outcome measure will be assessed for all three cohorts
- 30-day mortality [ Time Frame: From October 2012 to October 2013 ]This outcome 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 ]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 ]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 ]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 ]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 ]This outcome measure will be assessed for all three cohorts
- Positive Likelihood Ratio = (Sensitivity / (1-specificity)) [ Time Frame: From October 2012 to October 2013 ]This outcome measure will be assessed for all three cohorts
- 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
- • 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718561
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 |
Principal Investigator: | Anders K Nørskov, MD | Hillerod Hospital, Denmark |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
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 |