The Difficult Airway Management Trial: "The DIFFICAIR-Trial" (DIFFICAIR)
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| ClinicalTrials.gov Identifier: NCT01718561 |
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Recruitment Status :
Completed
First Posted : October 31, 2012
Last Update Posted : February 10, 2014
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Sponsor:
Hillerod Hospital, Denmark
Collaborators:
Copenhagen Trial Unit, Center for Clinical Intervention Research
TrygFonden, Denmark
Information provided by (Responsible Party):
Anders Nørskov, Hillerod Hospital, Denmark
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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 |
Show Detailed Description
| 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 |
|---|---|
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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 |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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, Older Adult) |
| 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..)
Information from the National Library of Medicine
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
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 |
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:
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Airway assessment Intubation Mask ventilation |
Additional relevant MeSH terms:
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Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |