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

This study has been completed.
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: February 7, 2014
Last verified: February 2014
  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 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 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: 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

Further study details as provided by Hillerod Hospital, Denmark:

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    This outcome 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 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 ] [ 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


  • • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 76058
Study Start Date: October 2012
Study Completion Date: January 2014
Primary Completion Date: December 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 risk factor for difficult mask ventilation. Registration in Danish Anesthesia Database

  Show Detailed Description

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718561

Locations
Denmark
Department of anesthesia, Hillerød Hospital
Hillerød, Region Hovedstaden, Denmark, 3400
Bispebjerg hospital
Copenhagen, Denmark
thoraxcentret Rigshospitalet
Copenhagen, Denmark
Neurocentret Rigshospitalet
Copenhagen, Denmark
Juliane Marie centret Rigshospitalet
Copenhagen, Denmark
Hovedorto centret Rigshospitalet
Copenhagen, Denmark
Abdominalcentret Rigshospitalet
Copenhagen, Denmark, 2100
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

No publications provided by Hillerod Hospital, Denmark

Additional 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
Study First Received: October 29, 2012
Last Updated: February 7, 2014
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 Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014