Difficult AirwayNCT02313168
F.R.O.N.T. Formula for Pre-operative Airway Assessment and Documentation
An observational study of Difficult Airway, run by University of Debrecen at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Airway
- What is being tested?
- observation, inspection
- How many people
- 1,150 participants
- Where
- 1 siteHungary
- Study dates
- Mar 2013to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients (over 18 years) going elective surgery.
Who may be able to join
- Age 18 years or older going to be intubated for general anesthesia for elective operation
Who cannot join
- age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The F.R.O.N.T. formula for pre-operative airway assessment and documentation
Background:
Read more
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.
Read the detailed description
Criteria for preoperative assessment and grading for all five levels "F" 0 Normal level of difficulty or no difficulty to be expected
- Difficulty to apply air tight the facial mask ventilation by one person (difficulty to maintain SpO2 above 92% with 100% O2), or inability to prevent the decrease in SpO2 during facial mask ventilation.
- Increased ventilation difficulty, requiring the presence of two anesthetists in order to maintain the patient's oxygenation, or inability to ventilate the patient with the facial mask.
"R" 0 Normal level of difficulty or no difficulty to be expected
- Incomplete teeth, loose teeth, edentulous status, incisor protrusion, prognathia, micrognathia, limited opening of the mouth but still more than 3 cm., expected difficulty with direct laringoscopy and/or insertion of a supraglottic device.
- Mobile teeth, mouth opening less than 3 cm, laryngoscopy or insertion of a supraglottic airway device impossible "O"
0 Normal level of difficulty or no difficulty to be expected
1 Laryngoscopy and intubation difficult expected by intaroral mass, abscess, anatomical anomalies (large tongue) 2 Laryngoscopy and tracheal intubation expected to be extremely difficult or impossible "N" 0 Normal level of difficulty or no difficulty to be expected
- Reduced mobility of the cervical spine, short neck, bulky chest, special positioning of the patient necessary (roll under the shoulders)
- Immobile cervical spine "T"
0 Normal level of difficulty or no difficulty to be expected
- Expected trouble for passing the tube through the glottis (polyp, tumor, abscess), and tube with smaller diameter necessary
- Severe obstruction in the upper airway (polyp, tumor, abscess, paralysis of the vocal cords), tracheal stenosis, tracheomalacia
Criteria for intraoperative assessment and grading for all five levels. "F" 0 Normal level of difficulty or no difficulty
- Difficulty to seal the face mask accordingly by one person in order to maintain SpO2 above 92% by ventilating with oxygen.
- Inability to maintain SpO2 above 92% by ventilating with oxygen with handling the face mask by two persons.
"R" 0 Normal level of difficulty or no difficulty
- Incomplete dentition, protruding incisives, prognathia, micrognathia, a reduced interincisive gap above 3 cm thus explicitly hampering (but not completely preventing) intubation or supraglottic device insertion.
- Incomplete dentition, protruding incisives, prognathia, micrognathia, a reduced interincisive gap below 3 cm limiting intubation or supraglottic device insertion.
"O" 0 Normal level of difficulty or no difficulty
- Macroglossia, presence of tumours or other findings with increased oral tissue mass, tongue base processes which hamper the performance of direct laryngoscopy (Cormack/Lehane grades up to 3°), conventional intubation or the insertion of a supraglottic airway. Final success could be achieved after two attempts to secure the airway with any adopted technique.
- Macroglossia, presence of tumours or other findings with increased oral tissue mass, tongue base processes which prevent the performance of direct laryngoscopy (Cormack/Lehane grade 4°), conventional intubation or the insertion of a supraglottic airway. Tracheal intubation could be achieved only after recurring to a visualizing technique (e.g. flexible fiberoptic).
"N" 0 Normal level of difficulty or no difficulty
- Reduced cervical spine mobility, short neck, risk of spinal cord damage by certain head positions that hamper direct laryngoscopy and conventional means of tracheal intubation. Successful intubation possible by 2 or more attempts. Supraglottic airway insertion is not affected.
- Reduced cervical spine mobility, short neck, risk of spinal cord damage by certain head positions that prevent direct laryngoscopy and conventional means of tracheal intubation. Tracheal intubation could be achieved only after recurring to a visualizing technique (e.g. flexible fiberoptic). Supraglottic airway insertion may have been affected.
"T" 0 Normal level of difficulty or no difficulty
- Difficult forwarding of a tracheal tube with regular diameter to a mid-tracheal position. Supraglottic airway insertion is not affected.
- Impossible forwarding of a tracheal tube even with a reduced diameter to a mid-tracheal position. Supraglottic airway insertion is not affected but ventilation is difficult or impossible. Necessity to apply jet ventilation or to bypass the oro-tracheal route by performing a trans-tracheal access.
- Conditions
- Difficult Airway
- Being tested
- observation, inspection
- Keywords
- difficult airway; prediction, FRONT score.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation, inspectionOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | preoperative FRONT score Receives: Other: observation, inspection | |
| 2 | intraoperative FRONT score Receives: Other: observation, inspection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks (between the preop. anesthesiological examination and the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Debrecen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Iuliu Hatieganu University of Medicine and Pharmacy
- Responsible party
- Principal investigator, Tamas Vegh, MD, University of Debrecen
- Investigators
- Bél Mr Fülesdi, MD, PhD, DSci, Principal investigator, Hungary University of Debrecen Debrecen, Hungary, 4032
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313168
- Sponsor's protocol ID
- AITT 2014/7
- Other IDs
- HBR/052/01763-2/2014, DE KK RKEB/IKEB 4231-2014
- Status last verified
- Mar 2017
- First submitted
- 5 Dec 2014
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F.R.O.N.T. Formula for Pre-operative Airway Assessment and Documentation
- ClinicalTrials.gov ID
- NCT02313168
- Acronym / sponsor ID
- AITT 2014/7
- Conditions
- Difficult Airway
- Keywords
- difficult airway; prediction, FRONT score.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- University of DebrecenUniversity, hospital or other
- Collaborators
- University of Zurich, Iuliu Hatieganu University of Medicine and Pharmacy
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Criteria for preoperative assessment and grading for all five levels "F" 0 Normal level of difficulty or no difficulty to be expected
- Difficulty to apply air tight the facial mask ventilation by one person (difficulty to maintain SpO2 above 92% with 100% O2), or inability to prevent the decrease in SpO2 during facial mask ventilation.
- Increased ventilation difficulty, requiring the presence of two anesthetists in order to maintain the patient's oxygenation, or inability to ventilate the patient with the facial mask.
"R" 0 Normal level of difficulty or no difficulty to be expected
- Incomplete teeth, loose teeth, edentulous status, incisor protrusion, prognathia, micrognathia, limited opening of the mouth but still more than 3 cm., expected difficulty with direct laringoscopy and/or insertion of a supraglottic device.
- Mobile teeth, mouth opening less than 3 cm, laryngoscopy or insertion of a supraglottic airway device impossible "O"
0 Normal level of difficulty or no difficulty to be expected
1 Laryngoscopy and intubation difficult expected by intaroral mass, abscess, anatomical anomalies (large tongue) 2 Laryngoscopy and tracheal intubation expected to be extremely difficult or impossible "N" 0 Normal level of difficulty or no difficulty to be expected
- Reduced mobility of the cervical spine, short neck, bulky chest, special positioning of the patient necessary (roll under the shoulders)
- Immobile cervical spine "T"
0 Normal level of difficulty or no difficulty to be expected
- Expected trouble for passing the tube through the glottis (polyp, tumor, abscess), and tube with smaller diameter necessary
- Severe obstruction in the upper airway (polyp, tumor, abscess, paralysis of the vocal cords), tracheal stenosis, tracheomalacia
Criteria for intraoperative assessment and grading for all five levels. "F" 0 Normal level of difficulty or no difficulty
- Difficulty to seal the face mask accordingly by one person in order to maintain SpO2 above 92% by ventilating with oxygen.
- Inability to maintain SpO2 above 92% by ventilating with oxygen with handling the face mask by two persons.
"R" 0 Normal level of difficulty or no difficulty
- Incomplete dentition, protruding incisives, prognathia, micrognathia, a reduced interincisive gap above 3 cm thus explicitly hampering (but not completely preventing) intubation or supraglottic device insertion.
- Incomplete dentition, protruding incisives, prognathia, micrognathia, a reduced interincisive gap below 3 cm limiting intubation or supraglottic device insertion.
"O" 0 Normal level of difficulty or no difficulty
- Macroglossia, presence of tumours or other findings with increased oral tissue mass, tongue base processes which hamper the performance of direct laryngoscopy (Cormack/Lehane grades up to 3°), conventional intubation or the insertion of a supraglottic airway. Final success could be achieved after two attempts to secure the airway with any adopted technique.
- Macroglossia, presence of tumours or other findings with increased oral tissue mass, tongue base processes which prevent the performance of direct laryngoscopy (Cormack/Lehane grade 4°), conventional intubation or the insertion of a supraglottic airway. Tracheal intubation could be achieved only after recurring to a visualizing technique (e.g. flexible fiberoptic).
"N" 0 Normal level of difficulty or no difficulty
- Reduced cervical spine mobility, short neck, risk of spinal cord damage by certain head positions that hamper direct laryngoscopy and conventional means of tracheal intubation. Successful intubation possible by 2 or more attempts. Supraglottic airway insertion is not affected.
- Reduced cervical spine mobility, short neck, risk of spinal cord damage by certain head positions that prevent direct laryngoscopy and conventional means of tracheal intubation. Tracheal intubation could be achieved only after recurring to a visualizing technique (e.g. flexible fiberoptic). Supraglottic airway insertion may have been affected.
"T" 0 Normal level of difficulty or no difficulty
- Difficult forwarding of a tracheal tube with regular diameter to a mid-tracheal position. Supraglottic airway insertion is not affected.
- Impossible forwarding of a tracheal tube even with a reduced diameter to a mid-tracheal position. Supraglottic airway insertion is not affected but ventilation is difficult or impossible. Necessity to apply jet ventilation or to bypass the oro-tracheal route by performing a trans-tracheal access.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: observation, inspectionpreoperative FRONT score |
| 2 | – | Other: observation, inspectionintraoperative FRONT score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients (over 18 years) going elective surgery.
Key inclusion criteria (1 listed)
- Age 18 years or older going to be intubated for general anesthesia for elective operation
Key exclusion criteria (1 listed)
- age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation, inspection | Other | 1, 2 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bél Mr Fülesdi, MD, PhD, DSci principal investigator
Hungary University of Debrecen Debrecen, Hungary, 4032
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Airway, run by University of Debrecen at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the preoperative and the intraoperative FRONT scores. (time frame: 2 weeks (between the preop. anesthesiological examination and the operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.