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F.R.O.N.T. Formula for Pre-operative Airway Assessment and Documentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02313168
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
University of Zurich
Iuliu Hatieganu University of Medicine and Pharmacy
Information provided by (Responsible Party):
Tamas Vegh, MD, University of Debrecen

Brief Summary:

The F.R.O.N.T. formula for pre-operative airway assessment and documentation

Background:

Prediction of difficult airway is one of the most important challenges before general anesthesia. Although in recent decades different scoring systems have been for the preoperative assessment of their sensitivity and specificity in predicting a difficult airway remains moderate. Recently, the calculation of composite scores using different formulae has been proposed as the most sensitive one. The aim of the present work was to test the clinical usefulness of the FRONT score, a recently developed scoring system.

Methods:

This study was a multi-center, inter-observer, prospective and double-blind investigation that included 976 patients from two university centers: 250 from the University of Cluj-Napoca, Romania, and 726 from the University of Debrecen, Hungary.

The preoperative evaluation of the patients was performed by a preoperative team of anesthesiologists (team A) who evaluated and scored the expected difficulty of the management of the airway. An intraoperative team of evaluators (team B) working independently from team A, performed the actual instrumentation of the airway and scored the actual findings. Both teams used the FRONT scoring system and worked independently from each other to ensure blinded assessment. Statistical analysis of the preoperative and intraoperative FRONT scores were performed post hoc.


Condition or disease Intervention/treatment
Difficult Airway Other: observation, inspection

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Study Type : Observational
Actual Enrollment : 1150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: F.R.O.N.T. Formula for Pre-operative Airway Assessment and Documentation
Actual Study Start Date : March 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Group/Cohort Intervention/treatment
1
preoperative FRONT score
Other: observation, inspection
2
intraoperative FRONT score
Other: observation, inspection



Primary Outcome Measures :
  1. Correlation between the preoperative and the intraoperative FRONT scores. [ Time Frame: 2 weeks (between the preop. anesthesiological examination and the operation) ]
    The preoperative evaluation of the patients was performed by a preoperative team of anesthesiologists (team A) who evaluated and scored the expected difficulty of the management of the airway. An intraoperative team of evaluators (team B) working independently from team A, performed the actual instrumentation of the airway and scored the actual findings. Both teams used the FRONT scoring system and worked independently from each other to ensure blinded assessment. Statistical analysis of the preoperative and intraoperative FRONT scores will be performed post hoc. (correlation analysis)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients (over 18 years) going elective surgery.
Criteria

Inclusion Criteria:

Age 18 years or older going to be intubated for general anesthesia for elective operation

Exclusion Criteria:

age under 18 years


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): NCT02313168


Locations
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Hungary
Hungary University of Debrecen
Debrecen, Hajdú-Bihar, Hungary, 4032
Sponsors and Collaborators
University of Debrecen
University of Zurich
Iuliu Hatieganu University of Medicine and Pharmacy
Investigators
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Principal Investigator: Bél Mr Fülesdi, MD, PhD, DSci Hungary University of Debrecen Debrecen, Hungary, 4032

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Responsible Party: Tamas Vegh, MD, assistant professor anesthesiologist and intensive care specialist, University of Debrecen
ClinicalTrials.gov Identifier: NCT02313168    
Other Study ID Numbers: AITT 2014/7
HBR/052/01763-2/2014 ( Registry Identifier: Government Offices Public Health Administration Organization )
DE KK RKEB/IKEB 4231-2014 ( Other Identifier: Local Ethic Comittee University of Debrecen )
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Keywords provided by Tamas Vegh, MD, University of Debrecen:
difficult airway; prediction, FRONT score.