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

NCT02313168 | Completed

• 3 other identifiers: AITT 2014/7HBR/052/01763-2/2014DE KK RKEB/IKEB 4231-2014
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Airway

Keywords

difficult airway; prediction, FRONT score.

Outcome Measures

Primary Outcomes (1)

• Correlation between the preoperative and the intraoperative FRONT scores.

  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)

  2 weeks (between the preop. anesthesiological examination and the operation)

Study Arms (2)

1

preoperative FRONT score

Other: observation, inspection

2

intraoperative FRONT score

Other: observation, inspection

Interventions

observation, inspection OTHER

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

adult patients (over 18 years) going elective surgery.

You may qualify if:

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

You may not qualify if:

• age under 18 years

Sponsors & Collaborators

• University of Debrecen: lead
• University of Zurich: collaborator
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator

Study Sites (1)

Hungary University of Debrecen

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

MeSH Terms

Interventions

Observation; Watchful Waiting

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Bél Mr Fülesdi, MD, PhD, DSci

  Hungary University of Debrecen Debrecen, Hungary, 4032

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor anesthesiologist and intensive care specialist

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

HU (1)