The Danish Anaesthesia Database and the Prediction of DIFFICult AIRway Management Trial: "The DIFFICAIR-Trial"
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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 |
- 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 ]
- 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 |
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| Contact: Anders K Nørskov, MD | +45 40103387 | anderskehlet@hotmail.com |
| 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 | |
| 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