Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02957084
Other study ID # 10634
Secondary ID
Status Completed
Phase N/A
First received October 29, 2016
Last updated November 3, 2016
Start date March 2013
Est. completion date December 2014

Study information

Verified date November 2016
Source National and Kapodistrian University of Athens
Contact n/a
Is FDA regulated No
Health authority Greece: National and Kapodistrian University of AthensGreece: Ministry of Health and Welfare, 7th Health Region of Crete
Study type Observational

Clinical Trial Summary

In this prospective, open cohort study the diagnostic value of tests based on neck anatomy in predicting difficult laryngoscopy was assessed.

The anatomic features of the neck measured were head extension, mouth opening, upper lip bite, Mallampati class, thyromental distance, sternomental distance, ratio of height to thyromental, neck circumference, thyrosternal distance, hyomental distance at full head extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental distance and ratio of hyomental distance FHE to hyomental distance NP.


Description:

Difficult airway assessment is based on various anatomic parameters of upper airway, much of it being concentrated on oral cavity and the pharyngeal structures. The diagnostic value of tests based on neck anatomy in predicting difficult laryngoscopy was assessed in this study .

The sample consisted of adult patients scheduled to receive general anaesthesia. Anatomic features of the neck were measured pre-operatively.

The anatomic features of the neck measured were thyromental distance, sternomental distance, ratio of height to thyromental, neck circumference, thyrosternal distance, hyomental distance at full head extension (FHE) and at neutral position (NP), ratio of neck circumference to thyromental distance and ratio of hyomental distance FHE to hyomental distance NP. The commonly used predictive tests head extension, mouth opening, upper lip bite test and Mallampati class were also measured.

The laryngoscopic view was classified according to the Cormack-Lehane Grade (1-4). Difficult laryngoscopy was defined as Cormack-Lehane Grade 3 or 4. Years of experience of the anaesthesiologists were recorded, as well as the number of tries needed to intubate the patient.

The optimal cut-off points for each predictive tests were identified by using receiver operating characteristic analysis. Sensitivity, specificity and positive predictive value and negative predictive value (NPV) were calculated for each test. Multivariate analysis with logistic regression, including all variables, was used to create a predictive model. Comparisons between genders were also performed to explore possible differences in diagnostic value and cut-off points. Finally, the years of experience of the clinician and the number of tries needed to intubate the patient were compared to assess risk of bias.


Recruitment information / eligibility

Status Completed
Enrollment 1142
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients

- BMI less than 35 kg/m2

- No known neck or airway pathology

- Scheduled for surgical procedures under general anaesthesia with tracheal intubation

Exclusion Criteria:

- Age less than 18 years

- BMI higher than 35 kg/m2

- Obvious airway malformations

- Need for rapid sequence induction/intubation under cricoid pressure

- Awake intubation

- Cervical spine pathology requiring specific manipulation

- Obstetric cases

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National and Kapodistrian University of Athens

References & Publications (22)

Burkle CM, Walsh MT, Harrison BA, Curry TB, Rose SH. Airway management after failure to intubate by direct laryngoscopy: outcomes in a large teaching hospital. Can J Anaesth. 2005 Jun-Jul;52(6):634-40. — View Citation

Cattano D, Panicucci E, Paolicchi A, Forfori F, Giunta F, Hagberg C. Risk factors assessment of the difficult airway: an italian survey of 1956 patients. Anesth Analg. 2004 Dec;99(6):1774-9, table of contents. — View Citation

Cheney FW. The American Society of Anesthesiologists Closed Claims Project: what have we learned, how has it affected practice, and how will it affect practice in the future? Anesthesiology. 1999 Aug;91(2):552-6. — View Citation

Chipas A, Ellis W, Zaglaniczny K. Airway management. In: Zaglaniczny K, Nagelhout J. Nurse Anesthesia. 3rd edition. USA: Elsevier Saunders; 2004:408

Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11. — View Citation

Crosby ET, Cooper RM, Douglas MJ, Doyle DJ, Hung OR, Labrecque P, Muir H, Murphy MF, Preston RP, Rose DK, Roy L. The unanticipated difficult airway with recommendations for management. Can J Anaesth. 1998 Aug;45(8):757-76. Review. — View Citation

Frova G, Sorbello M. Algorithms for difficult airway management: a review. Minerva Anestesiol. 2009 Apr;75(4):201-9. Review. — View Citation

Greek Society for Airway management, Basic and Advanced Management of the Airway, 2nd edition, Athens, 2011

Gupta S, Sharma R, Jain D. Airway assessment: predictors of difficult airway. Indian J Anaesth. 2005:49(4):257-62

Huh J, Shin HY, Kim SH, Yoon TK, Kim DK. Diagnostic predictor of difficult laryngoscopy: the hyomental distance ratio. Anesth Analg. 2009 Feb;108(2):544-8. doi: 10.1213/ane.0b013e31818fc347. — View Citation

Khan ZH, Kashfi A, Ebrahimkhani E. A comparison of the upper lip bite test (a simple new technique) with modified Mallampati classification in predicting difficulty in endotracheal intubation: a prospective blinded study. Anesth Analg. 2003 Feb;96(2):595-9, table of contents. — View Citation

Koay CK. Difficult tracheal intubation--analysis and management in 37 cases. Singapore Med J. 1998 Mar;39(3):112-4. — View Citation

Lundstrøm LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431. — View Citation

Naguib M, Malabarey T, AlSatli RA, Al Damegh S, Samarkandi AH. Predictive models for difficult laryngoscopy and intubation. A clinical, radiologic and three-dimensional computer imaging study. Can J Anaesth. 1999 Aug;46(8):748-59. — View Citation

Patil VU, Stehling LC, Zauder HL. Predicting the difficulty of intubation utilizing an intubation gauge. Anesthesiol Rev. 1983;10:32-3.

Peterson GN, Domino KB, Caplan RA, Posner KL, Lee LA, Cheney FW. Management of the difficult airway: a closed claims analysis. Anesthesiology. 2005 Jul;103(1):33-9. — View Citation

Rose DK, Cohen MM. The airway: problems and predictions in 18,500 patients. Can J Anaesth. 1994 May;41(5 Pt 1):372-83. — View Citation

Rucker JC, Cole D, Guerina LR, Zoran N, Chung F, Friedman Z. A prospective observational evaluation of an anatomically guided, logically formulated airway measure to predict difficult laryngoscopy. Eur J Anaesthesiol. 2012 May;29(5):213-7. doi: 10.1097/EJA.0b013e3283502168. — View Citation

Savva D. Prediction of difficult tracheal intubation. Br J Anaesth. 1994 Aug;73(2):149-53. — View Citation

Schmitt HJ, Kirmse M, Radespiel-Troger M. Ratio of patient's height to thyromental distance improves prediction of difficult laryngoscopy. Anaesth Intensive Care. 2002 Dec;30(6):763-5. — View Citation

Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. — View Citation

Türkan S, Ates Y, Cuhruk H, Tekdemir I. Should we reevaluate the variables for predicting the difficult airway in anesthesiology? Anesth Analg. 2002 May;94(5):1340-4, table of contents. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Difficult laryngoscopy classification using Cormack-Lehane Grade Assessment of difficult laryngoscopy at the time of the airway management procedure. Classified as Grade I - visualization of entire laryngeal aperture, grade II - visualization of only posterior commissure of laryngeal aperture, grade III - visualization of only epiglottis, grade IV - visualization of just the soft palate. immediate No
Secondary Thyromental distance measured in cm with a measuring tape The distance from the mentum to the thyroid notch while the patient's neck is fully extended and the mouth closed immediate No
Secondary Sternomental distance measured in cm with a measuring tape The distance from the suprasternal notch to the mentum while the patient's neck is fully extended and the mouth closed immediate No
Secondary Ratio of height to thyromental distance Calculated ratio of the height in cm to the aforementioned thyromental distance immediate No
Secondary Thyrosternal distance calculated in cm Calculated from the subtraction: sternomental (cm) minus thyromental (cm) immediate No
Secondary Neck circumference measured in cm with a measuring tape Measurement at the level of the cricoid cartilage while the patient's neck is in neutral position immediate No
Secondary Ratio of neck circumference to thyromental distance Calculated ratio of the neck circumference to the aforementioned thyromental distance immediate No
Secondary Hyomental distance at full head extension (FHE) measured in cm with a measuring tape The distance from the mentum to the hyoid bone while the patient's neck is fully extended and the mouth closed immediate No
Secondary Hyomental distance at neutral position (NP) measured in cm with a measuring tape The distance from the mentum to the hyoid bone while the patient's neck is in neutral position and the mouth closed immediate No
Secondary Ratio of hyomental distance at FHE to hyomental distance at NP Calculated ratio of the aforementioned variables immediate No
Secondary Mallampati class Classified as class I - soft palate, fauces, uvula, and pillars seen, class II - soft palate, fauces, and uvula seen, class III - soft palate and base of uvula seen and class IV - soft palate not visible. immediate No
Secondary Mouth opening measured in cm with a measuring tape The distance between the upper and lower incisors with the mouth fully open immediate No
Secondary Upper lip bite test Classified as class I - lower incisors can bite the upper lip above the vermilion line, class II - lower incisors can bite the upper lip below the vermilion line and class III - lower incisors cannot bite the upper lip. immediate No
Secondary Head extension measured in degrees with goniometer The patient was asked to hold head erect, facing directly to the front, then asked to extend the head maximally and the examiner estimated the angle traversed by the occlusal surface of upper teeth using a goniometer. immediate No
See also
  Status Clinical Trial Phase
Completed NCT03908411 - The Effect of Paratracheal Pressure on the Glottic View N/A
Completed NCT04564105 - Simulation Training and Teamwork Concerning Intubation on the Icu N/A
Completed NCT02988336 - TMHT - New Method of Difficult Intubation Prediction N/A
Completed NCT03002857 - Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery N/A
Recruiting NCT06337006 - Laryngeal Mask Airway Failure in Pediatric Patients
Completed NCT03443219 - RCT- LMA Supremeā„¢ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients N/A
Completed NCT05044416 - VieScope in Patients With an Expected Difficult Airway N/A
Not yet recruiting NCT05534451 - Comparison Among Three Different Video Scope Guided Nasotracheal Intubation. N/A
Recruiting NCT06073977 - Risk Factors for Pediatric Difficult Supraglottic Airway Placement and Ventilation
Not yet recruiting NCT03687385 - The Effect of High-flow Nasal Oxygenation to the Saturation During Analgo-sedation in Different ASA Risk Class Patients N/A
Not yet recruiting NCT03687424 - Can High-flow Nasal Oxygenation Improve Oxygen Saturation During Analgo-sedation in Obese Adults? N/A
Enrolling by invitation NCT05055401 - Airway Management Skills Amongst Anesthesia Providers
Not yet recruiting NCT02920879 - Airway Effects of PEEP During Anesthesia Induction. N/A
Terminated NCT02644837 - AuraGain and iGel Crossover Comparison N/A
Completed NCT02263300 - Spatial Orientation and Fiberoptic Intubation Skills in the Novice: A Randomized Controlled Trial
Completed NCT01718561 - The Difficult Airway Management Trial: "The DIFFICAIR-Trial" N/A
Completed NCT01635660 - Out-of-Hospital Randomized Comparison of Video-assisted Endotracheal Intubation N/A
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00892671 - Airway Management and Vascular Access Simulation N/A
Completed NCT03848559 - Airway Management With Simulated Microgravity Using a Submerged Model N/A