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

NCT01718561 | Completed

• 1 other identifier: DIFFICAIR
• Study Type: interventional
• Target: 76,058
• Locations: 1 country
• Sites: 28

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.

Conditions

Airway Management; Intubation, Intratracheal

Keywords

Airway assessment; Intubation; Mask ventilation

Outcome Measures

Primary Outcomes (2)

• Fraction of unanticipated difficult intubations = intubations with unanticipated difficulties [False negative] / all patients primarily (attempted) intubated by direct laryngoscopy

  This outcome measure will also be assessed for mask ventilation instead of intubation

  From October 2012 to December 2013

• Fraction of unanticipated easy intubations = intubations with anticipated difficulties that were easy [False Positive] / all patients primarily (attempted) intubated by direct laryngoscopy

  This outcome measure will also be assessed for mask ventilation instead of intubation

  From October 2012 to December 2013

Secondary Outcomes (10)

• 48 hour mortality

  From October 2012 to October 2013

• 30-day mortality

  From October 2012 to October 2013

• unexpected difficult intubation [False Negative] / actual difficult intubation ([False-negative] + [True Positive]).

  From October 2012 to October 2013

• Sensitivity: [True Positive] / ([Sand Positive] + [False Negative]).

  From October 2012 to October 2013

• Specificity: [True Negative] / ([True Negative] + [False Positive])

  From October 2012 to October 2013

Study Arms (2)

Control

NO INTERVENTION

Usual clinical airway evaluation and usual registration in Danish Anaesthesia Database (without SARI registration)

SARI

EXPERIMENTAL

Registration of Modified SARI score and predictors for difficult mask ventilation in Danish Anaesthesia Database

Procedure: SARI

Interventions

SARI PROCEDURE

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

SARI

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• Children under 15 years
• Patients who can not co-operate for the examination (unconscious, demented, severely traumatized, etc..)

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• TrygFonden, Denmark: collaborator

Study Sites (28)

Department of anesthesia, Hillerød Hospital

Hillerød, Capital Region, 3400, Denmark

Location

Åbenrå sygehus

Aabenraa, Denmark

Location

Aleris-Hamlet

Aalborg, Denmark

Location

Aleris-Hamlet

Aarhus, Denmark

Location

Abdominalcentret Rigshospitalet

Copenhagen, 2100, Denmark

Location

Bispebjerg hospital

Copenhagen, Denmark

Location

Hovedorto centret Rigshospitalet

Copenhagen, Denmark

Location

Juliane Marie centret Rigshospitalet

Copenhagen, Denmark

Location

Neurocentret Rigshospitalet

Copenhagen, Denmark

Location

thoraxcentret Rigshospitalet

Copenhagen, Denmark

Location

Aleris-Hamlet

Esbjerg, Denmark

Location

Frederiksberg hospital

Frederiksberg, Denmark

Location

Glostrup Hospital

Glostrup Municipality, Denmark

Location

Haderslev Hospital

Haderslev, Denmark

Location

Bekkevold klinikken

Hellerup, Denmark

Location

Herlev Hospital

Herlev, Denmark

Location

Aleris-Hamlet

Herning, Denmark

Location

Kolding sygehus

Kolding, Denmark

Location

Kollund privathospital

Kollund, Denmark

Location

Københavnsprivathospital

Lyngby, Denmark

Location

Nykøbing falster sygehus

Nykøbing Falster, Denmark

Location

Næstved Hospital

Næstved, Denmark

Location

Roskilde Sygehus

Roskilde, Denmark

Location

Bornholm sygehus

Rønne, Denmark

Location

Aleris-Hamlet

Søborg, Denmark

Location

Sønder sygehus

Sønderborg, Denmark

Location

Thisted sygehus

Thisted, Denmark

Location

Vejle Sygehus

Vejle, Denmark

Location

Related Publications (3)

• Norskov AK, Wetterslev J, Rosenstock CV, Afshari A, Astrup G, Jakobsen JC, Thomsen JL, Bottger M, Ellekvist M, Schousboe BM, Horn A, Jorgensen BG, Lorentzen K, Madsen MH, Knudsen JS, Thisted BK, Estrup S, Mieritz HB, Klesse T, Martinussen HJ, Vedel AG, Maaloe R, Bosling KB, Kirkegaard PR, Ibanez CR, Aleksandraviciute G, Hansen LS, Mantoni T, Lundstrom 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.

  PMID: 27106972 DERIVED

• Norskov AK, Lundstrom 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.

  PMID: 24885548 DERIVED

• Norskov AK, Rosenstock CV, Wetterslev J, Lundstrom 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.

  PMID: 24152537 DERIVED

Study Officials

• Anders K Nørskov, MD

  Hillerod Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, clinical assistant

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: October 31, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

DK (28)