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

NCT01718561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76058

Last updated 2014-02-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • TrygFonden, Denmark

    collaborator INDUSTRY

  • Hillerod Hospital, Denmark

    lead OTHER

Principal Investigators

  • Anders K Nørskov, MD · Hillerod Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01718561 on ClinicalTrials.gov