ultrasound use for assessment of difficult airway identifiers.

Not yet recruiting

Conditions: Failed or difficult intubation, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2018/10/016127

Lead Sponsor: AIIMS JODHPUR

Brief Summary: Introduction

A difficult airway is defined as the clinical situation in which a conventionally trained anesthesiologist experiences difficulty with mask or supraglottic airway (SGA) ventilation, difï¬cult SGA placement, difï¬cult or failed endotracheal intubation, and difï¬cult laryngoscopy.1Even with proper preoperative evaluation only 15-50% of difficult airways are identified.2 A patent and secured airway is important to maintain anaesthetized patient, but, difficult airway and intubation remains major factors contributing to mortality and morbidity in anaesthetized patients.

The consequences of failing to predict and prepare for a difficult intubation may range from transient haemodynamic changes to hypoxic brain injury and cardiac arrest.3 Accurate airway assessment will reduce the number of unanticipated difficult airway. Different parameters have been and are being used to predict difficult airways clinically.4, 5 In clinical assessment mouth opening, neck movements (occipitoatlantoaxial extension), ability to prognath, modified Mallampati grade, Wilson risk score, thyromental distance, sternomental distance, body weight >110 kg, neck circumference, indirect laryngoscopy etc. Still clinical screening is not that much accurate in predicting difficult airway and direct laryngoscopy remains the gold standard parameter.

Ultrasonography is a simple, bedside, cost-effective, reproducible, noninvasive diagnostic tool used by many anaesthesiologists in their daily routine practice in operation theatre and ICU. With the help of ultrasound, we can visualize upper airway anatomy and pathologies, estimate the endotracheal tube size to be placed and predict difficult laryngoscopy. Knowing sonoanatomy preoperatively will help us to be ready with preparation and essential instruments.4Even though Ultrasound machines are capable of diagnosing difficult airways still they are not used routinely for airway assessment. There is a pressing need of comparing standard airway indicators and ultrasound indicators taking ease (or absence of it) of laryngoscopy as the outcome criteria to evaluate and validate the sonographic difficult airway predictors, that is why, we plan to do this study.

                     Review of literature

Unanticipated difficult intubation is one of the greatest challenges for emergency physicians and anaesthesiologists. There are several traditional indices of predicting difficult laryngoscopy, but none of them are 100% sensitive andâ€‹ specific. Ultrasound is a new addition to the anaesthesiologistsâ€™ armamentarium, which has revolutionized care in several areas. The role of ultrasound in airway assessment is still primitive, with no established standard parameters to predict a difficult laryngoscopy. Airway sonography is a bedside non-invasive diagnostic tool that enables the visualization and measurement of dimensions that may be related to the prediction of difficult airway management. Despite the diagnostic potential for identification of patients with likely difficult intubation, airway sonography is still not commonly used during airway assessment.

Reason for this situation is a lack of evidence supporting the validity of airway sonography. Although several airway sonographic parameters have been shown as possible indicators of difficult laryngoscopy in small studies, the search for a simple and accurate measure continues.

Andruszkiewicz et al in their study demonstrated that sonographic parameters evaluated during submandibular examination may help identify patients with difficult laryngoscopy. Individual measures have unsatisfactory diagnostic profiles in predicting difficult laryngoscopy. Combined models consisting of sonographic (hyomental distance in extension and tongue volume) and clinical tests improved the diagnostic value. Additionally, a submandibular sonographic examination can be a valuable tool to enrich a multimodal preoperative airway assessment.4

Fulkerson et al conducted a review to evaluate existing literature on the predictive value of airway ultrasound for difficult intubation, defined as Cormackâ€“Lehane grade III or IV under direct laryngoscopy.5 The intent of this review was to synthesize the current literature and raise the evidence level evaluating this modality in the difficult airway assessment. They observed that, despite differences in sample characteristics and measurement techniques across studies, airway ultrasound holds early predictive value to detect the difficult airway and significance for difficult intubation has been established by visualization of the hyoid bone, measurement of the hyomental distance with neck extension, and the measurement of anterior soft tissue thickness at the thyrohyoid membrane. They emphasized upon need for standardized studies using a larger sample with standardized positioning and a well-defined scanning protocol to correlate this diagnostic modality to difficult intubation or reject its use.

Adhikari et al. used ultrasound to determine the utility of sonographic measurements of thickness of the tongue, anterior neck soft tissue at the level of hyoid bone, and the thyrohyoid membrane in distinguishing between easy and difficult laryngoscopy. They demonstrated that sonographic measurements of anterior neck soft tissue thickness at the level of hyoid bone and thyrohyoid membrane could be used to distinguish easy from difficult laryngoscopy.6

Wu et al. in their study on 203 patients, have shownâ€‹that the thickness of the anterior neck soft tissue can be a predictor of difficult laryngoscopy. They found that the skin to hyoid distance as well as skin to epiglottis distance were good predictors of difficult laryngoscopy.7

Wojtczak et al in their study on five obese and seven morbidly obese patients, did not find the tongue volume to differ between easy and difficult laryngoscopy. The difference could bebecause the tongue volume should be taken in relation to the mandibular volume.8

Ezri et al measured the neck soft tissue distance from skin to anterior aspect of the trachea at the vocal cords, using ultrasound in fifty obese patients and found that patients with larger neck circumference and more pretracheal soft tissue had difficult laryngoscopy.9

Hui et al have recently shown that visibility of hyoid bone on a sublingual ultrasound could be predictive of easy laryngoscopy. Their technique did not take much time to perform, and they showed that the inability to visualize the hyoid bone through a sublingual sonographic scan is predictive of a difficult laryngoscopy.10

According to Yao W et al; compared with indirect assessments, such as mouth opening and other parameters, mandibular condylar mobility, as assessed directly using sonography, correlates with difficult laryngoscopy and demonstrates an independent and notably predictive property.11

Saranya et al conducted prospective observational study with 141 patients, who were to undergo elective surgery under general anesthesia and required endotracheal intubation. They concluded that ultrasound can be used as a reliable tool to identify difficult airway by measuring the thickness of soft tissues in the anterior part of neck. They also found significant correlation between the thickness of soft tissue at the thyrohyoid membrane level and difficulty in intubation. 12

Parameswari et al conducted a prospective study to prove a correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients and concluded that skin to epiglottis distance, as measured at the level of the thyrohyoid membrane, is a good predictor of difficult laryngoscopy. When combined with the modified Mallampatticlassification, the sensitivity of the combined parameter was found to be greater than any single parameter taken alone.13

W. Yao and Bin Wang in their study showed that tongue thickness measured by ultrasonography and its ratio to thyromental distance present significant capacities to predict difficult tracheal intubation.14

Buono RD et al in their pilot study, though didnâ€™t find any statistical significance, but commented that anterior neck fat volume could have a potential predictive role for difficult intubation.15

Literature review suggest that individual measures have unsatisfactory diagnostic profiles in predicting difficult laryngoscopy. Combined models consisting of sonographic (hyomentaldistance in extension and tongue volume) and clinical tests can improve the diagnostic value.Additionally, a submandibular sonographic examination can be a valuable tool to enrich a multimodal preoperative airway assessment.

         Aims and objectives

We plan to record clinical and sonographic airway predictors in patients of age group 18-60 years; posted for routine elective surgeries; in the pre-operative period. We will, then evaluate and compare their ability to predict difficult laryngoscopy and intubation.

Primary aim

1. To evaluate the effectiveness of sonography based airway assessment parameters as predictors of difficult laryngoscopy and intubation using Cormackâ€“Lehane (CL) grade and intubation difficulty scale respectively

Secondary aims

1. Simultaneous evaluation of predictive ability of clinical airway predictors

2. Comparison of efficacy of clinical and sonographic airway parameters as tools of predicting difficult airway

3. Possible development of a model for prediction of difficult airway

      Material & Methods

For conducting the study Institutional ethics committee approval will be taken and written informed consent will be obtained from the participants. This study will also be registered with clinical trial registry.

Study setting

Patients included in this study group will be assessed preoperatively and during intubation in OT, AIIMS Jodhpur.

Study Design

Cross sectional study.

Sample size calculation

The study will be done on 130 patients (Assuming the incidence of difficult airway is 10% as suggested by previous observational studies, taking alpha error of 5% and power of study as 80% for two tailed data.

Methodology:

Patient selection criteria:

Inclusion criteria-

Patients in the age group of 18- 60 years, undergoing elective surgical procedures, which require intubation and neuromuscular blockade.

Exclusion criteria

1. Known tongue, oropharyngeal, laryngeal, or head and neck cancers, tumors, or anatomy-altering conditions

2. Any notable swelling, scarring, cysts; ongoing infections in the mouth, head, or neck.

3. Facial fractures

4. Cervical spine fracture/ instability

5. Inability to insert Macintosh blade in the oral cavity for laryngoscopy

6. Full stomach/ emergency intubations/ altered levels of consciousness

7. Tracheostomised patients

8. Refusal or inability to give consent

Detailed preoperative airway evaluation on the day before surgery; reviewed on the day of surgery.

Parameters observed during preoperative assessment:

Demographic parameters like Age, Sex, Weight, Body Mass Index (BMI), ASA status and comorbidities will be measured.

Parameters used for airway assessment:

Pre-operative clinical Airway assessment-

Mouth opening (inter-incisor gap)

Neck movements

Modified Mallampatti grade

Thyromental distance

Mentohyoid distance

Jaw protrusion/ Upper lip bite test

Neck circumference at the level of larynx

Mallampati classification with the Samsoon and Young modification with the patient in an upright sitting position, head in a neutral position, mouth wide open, and tongue protruding to its maximum without phonation (class I, soft palate, fauces, pillars, and uvula visible; class II, soft palate, fauces, and uvula visible; class III, only soft palate and base of uvula visible; and class IV, only hard palate visible) 16, 17

Thyromental distanceâ€”the distance in centimetres between the tip of the mandible to the anterior aspect of the thyroid cartilage with the neck fully extended. 18

Upper lip bite testâ€”assessed and categorized by the ability to bite the upper lip by the lower incisors (class 1, lower incisor can hide mucosa of the upper lip; class 2, lower incisor can partially hide mucosa of the upper lip; and class 3, lower incisor is unable to touch mucosa of the upper lip.19

Preoperative sonographic assessment:

Detailed preoperative sonographic assessment by the anaesthesiologist experienced in airway ultrasound.

Patient position- supine position with head in the neutral ((hyomental distances in the neutral position and extended) position without pillow, looking straight ahead with the mouth closed and the tongue on the floor of the mouth without any movement. with the transducer placed at the submandibular area in the sagittal and transverse planes

Airway sonography will be done before the operation in the pre-anaesthesia area using linear probe (5-10 MHZ) and Curvilinear probe (2-5 MHZ) of the ultrasound machine (SonositeMicromaxx, SonoSite Inc., Bothell, WA)

Sonographer will be blinded to clinical airway predictors and Cormack-Lehane grades.

Ultrasound parameters to be seen-

1. Hyomental distance in neutral and extended head positions (HMDN, HMDE)- measured in sagittal scans from the upper border of the hyoid bone to the lower border of the mentum of the mandible in a neutral position and a position with a maximally extended neck

2. Hyomental distance Ratio (HMDR- Hyomental distance in the neutral and head extended positions)

3. Hyoid bone visibility

4. Skin to epiglottis distance- measured at the level of the thyrohyoid membrane

5. Skin to hyoid distance

6. Anterior neck soft tissue thickness at the level of the vocal card

7. Tongue width- distance (centimetres) measured in transverse scans in the midsection of the tongue between the most distant points of its upper surface of the genioglossus muscle

8. Tongue cross-sectional area- in the sagittal scans by tracking the borders of the tongue muscles

9. Tongue volume- derived from multiplication of the midsagittal cross-sectional area by the tongue width

10. Pre E (Skin to epiglottis distance) /Eâ€‘VC ratio {(Depth of the preâ€‘epiglottic space (Preâ€‘E)/distance from the epiglottis to the midpoint of the vocal cords (Eâ€‘VC)}

11. Mandibular condylar mobility

Time taken to do the scanning will also be noted

Anaesthesia: Patient will be then taken inside the operating room and general anaesthesia with muscle relaxant will be administered as per institution protocol and standard of care.

Laryngoscope guided intubation by anaesthesiologists with at least 6 years of experience in laryngoscopy and airway management, who will also record Cormack- Lehane grade and calculate intubation difficulty scale score.

             Statistical analysis plan

For comparison of continuous variables between the groups, the Student t test will be used. The association between different predictors and difficult laryngoscopy will be evaluated using Chi-square test and Fisherâ€™s exact test. A p value < 0.05 will be considered to be significant.

Univariate logistic regression will be used to assess the accuracy, sensitivity, specificity, positive and negative likelihood ratios, and positive and negative predictive values of the collected data. Multivariate (stepwise selection method with probability for removal of .05) logistic regression analyses will be performed to identify independent classic and sonographic determinants of difficult laryngoscopy. To determine the discriminative power of individual tests and the combination, receiver-operating characteristic (ROC) analysis will be done and the area under the curve (AUC) with 95% confidence interval will be calculated.

        Ethical considerations

â€¢ This is a cross sectional study and involves routine anaesthesia steps, practiced in all elective surgeries.

â€¢ The study is ethical as all the preoperative assessment used in the study are standard, safe & widely used.

â€¢ This study is completely non-invasive and doesnâ€™t involve any financial assistance

â€¢ Patient comfort will be ensured

â€¢ Informed written consent in patientâ€™s own language & in English will be taken.

â€¢ They will be given full information about the study & the procedure they are undergoing.

â€¢ Strict confidentiality about the patient information will be maintained.

     Bibliography

1. Caplan R A, Posner K L, Ward RJ, Cheney F W. Adverse respiratory events in anesthesiaâ€¯: closed claims analysis.â€¯[Anesthesiology.](https://www.ncbi.nlm.nih.gov/pubmed/?term=Caplan+R+A%2C+Posner+K+L%2C+Ward+RJ%2C+Cheney+F+W.+Adverse+respiratory+events+in+anesthesia%E2%80%AF%3A+closed+claims+analysis) 1990;72:828-33.

2. Rose DK1, Cohen MM. The incidence of airway problems depends on the definition used. Can J Anaesth. 1996 ;43:30-4.

3. Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. [Anesthesiology.](https://www.ncbi.nlm.nih.gov/pubmed/?term=3.%09Schwartz+DE%2C+Matthay+MA%2C+Cohen+NH%3A+Death+and+other+complications+of+emergency+airway+management+in+critically+ill+adults.) 1995;82:367-76.

4. [Andruszkiewicz P](https://www.ncbi.nlm.nih.gov/pubmed/?term=Andruszkiewicz%20P%5BAuthor%5D&cauthor=true&cauthor_uid=27582532), [Wojtczak J](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wojtczak%20J%5BAuthor%5D&cauthor=true&cauthor_uid=27582532), [Sobczyk D](https://www.ncbi.nlm.nih.gov/pubmed/?term=Sobczyk%20D%5BAuthor%5D&cauthor=true&cauthor_uid=27582532), [Stach O](https://www.ncbi.nlm.nih.gov/pubmed/?term=Stach%20O%5BAuthor%5D&cauthor=true&cauthor_uid=27582532), [Kowalik I](https://www.ncbi.nlm.nih.gov/pubmed/?term=Kowalik%20I%5BAuthor%5D&cauthor=true&cauthor_uid=27582532). Effectiveness and Validity of Sonographic Upper Airway Evaluation to Predict Difficult Laryngoscopy. [J Ultrasound Med.](https://www.ncbi.nlm.nih.gov/pubmed/?term=Effectiveness+and+Validity+of+Sonographic+Upper+Airway+Evaluation+to+Predict+Difficult+Laryngoscopy) 2016;35:2243-52.

5. Fulkerson JS, Moore HM, Anderson TS, Lowe RF Jr. Ultrasonography in the preoperative difficult airway assessment. J Clin Monit Comput. 2017;31:513-30.

6. Adhikari S, Zeger W, Schmier C, Crum T, Craven A, Frrokaj I, et al. Pilot study to determine the utility of point-of-care ultrasound in the assessment of difficult laryngoscopy. Acad Emerg Med 2011;18:754â€‘8.

7. Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifications by ultrasound in predicting difficult laryngoscopy. Med Sci Monit 2014;20:2343â€‘50.

8. Wojtczak JA. Submandibular sonography: Assessment of hyomental distances and ratio, tongue size, and floor of the mouth musculature using portable sonography. J Ultrasound Med 2012;31:523â€‘8.

9. Ezri T, Gewu Â¨rtz G, Sessler DI, et al. Prediction of difï¬cult laryngoscopy in obese patients by ultrasound quantiï¬cation of anterior neck soft tissue\*. Anaesthesia. 2003;58:1111â€“4.

10. Hui CM, Tsui BC. Sublingual ultrasound as an assessment method for predicting difï¬cult intubation: a pilot study. Anaesthesia. 2014;69:314â€“9

11. [Yao W](https://www.ncbi.nlm.nih.gov/pubmed/?term=Yao%20W%5BAuthor%5D&cauthor=true&cauthor_uid=28098589)1, [Zhou Y](https://www.ncbi.nlm.nih.gov/pubmed/?term=Zhou%20Y%5BAuthor%5D&cauthor=true&cauthor_uid=28098589), [Wang B](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wang%20B%5BAuthor%5D&cauthor=true&cauthor_uid=28098589), [Yu T](https://www.ncbi.nlm.nih.gov/pubmed/?term=Yu%20T%5BAuthor%5D&cauthor=true&cauthor_uid=28098589), [Shen Z](https://www.ncbi.nlm.nih.gov/pubmed/?term=Shen%20Z%5BAuthor%5D&cauthor=true&cauthor_uid=28098589), [Wu H](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wu%20H%5BAuthor%5D&cauthor=true&cauthor_uid=28098589), [Jin X](https://www.ncbi.nlm.nih.gov/pubmed/?term=Jin%20X%5BAuthor%5D&cauthor=true&cauthor_uid=28098589), [Li Y](https://www.ncbi.nlm.nih.gov/pubmed/?term=Li%20Y%5BAuthor%5D&cauthor=true&cauthor_uid=28098589). Can Mandibular Condylar Mobility Sonography Measurements Predict Difficult Laryngoscopy? Anesth Analg 2017;124:800â€“6

12. Saranya, Raj S, Lingraj K. A prospective observational study to determine the usefulness of ultrasound guided airway assessment preoperatively in predicting difficult airway. Indian J Res. 2017;6:77-83

13. Parameswari A, Govind M, Vakamudi M. Correlation between preoperative ultrasonographic airway assessment and laryngoscopic view in adult patients: A prospective study. J Anaesthesiol Clin Pharmacol 2017;33:353-8.

14. [Yao W](https://www.ncbi.nlm.nih.gov/pubmed/?term=Yao%20W%5BAuthor%5D&cauthor=true&cauthor_uid=28403413), [Wang B](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wang%20B%5BAuthor%5D&cauthor=true&cauthor_uid=28403413). Can tongue thickness measured by ultrasonography predict difficult tracheal intubation? [Br J Anaesth.](https://www.ncbi.nlm.nih.gov/pubmed/?term=Can+tongue+thickness+measured+by+ultrasonography+predict+difficult+tracheal+intubation%3F) 2017;118:601-609

15. Buono RD, Sabatino L, Greco F. Neck fat volume as a potential indicator of difficult intubation: A pilot study. Saudi J Anaesth 2018;12:67-71.

16. Samsoon GLT, Young JRB. Difficult tracheal intubation: a retrospective study. Anaesthesia 1987; 42:487â€“490.

17. Mallampati SR. Clinical sign to predict difficult tracheal intubation (hypothesis). Can Anaesth Soc J 1983; 30:316â€“317. 11.

18. Ramachandran SK, Kheterpal S. The expected difficult airway. In: Glick DB, Cooper RM, Ovassapian A (eds). The Difficult Airway: An Atlas of Tools and Techniques for Clinical Management. 1st ed. New York, NY: Springer Science & Business Media; 2013:11â€“32.

19. 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; 96:595â€“599.

                 Appendix -1

All India Institute of Medical Sciences, Jodhpur, Rajasthan

Informed Consent Form

Title of Thesis/Dissertation: Evaluation of predictive performance of sonographic airway assessment parameters and comparison of their efficacy to predict difficult airway with clinical airway predictors: A Cross sectional study.

Name of PG Studentâ€‹â€‹â€‹:Dr.U. Anushaprasath   Tel. No.7010973507

Patient/Volunteer Identification No.â€‹:â€‹\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹â€‹

I, \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_S/o or D/o \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

R/o\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

give my full, free, voluntary consent to be a part of the study â€œEvaluation of predictive performance of sonographic airway assessment parameters and comparison of their efficacy to predict difficult airway with clinical airway predictors.â€ the procedure and nature of which has been explained to me in my own language to my full satisfaction. I confirm that I have had the opportunity to ask questions.

I understand that my participation is voluntary and am aware of my right to opt out of the study at any time without giving any reason.

I understand that the information collected about me and any of my medical records may be looked at by responsible individual from AIIMS Jodhpur or from regulatory authorities. I give permission for these individuals to have access to my records.

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹â€‹â€‹\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Place: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹   Signature/Left thumb impression

This to certify that the above consent has been obtained in my presence.

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹â€‹â€‹â€‹\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Place: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹â€‹â€‹   Signature of PG Student

1. Witness 1 â€‹â€‹â€‹â€‹â€‹â€‹2. Witness 2â€‹â€‹

Signatureâ€‹â€‹â€‹â€‹â€‹â€‹Signature

Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹â€‹Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Address: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_â€‹â€‹â€‹Address: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

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Appendix -2

PATIENT INFORMATION SHEET

1. Risks to the patients: No additional risk. No invasive interventions or life-threatening procedure will be done.

2. Confidentiality: Your participation will be kept confidential. Your medical records will be treated with confidentiality and will be revealed only to doctors/ scientists involved in this study. The results of this study may be published in a scientific journal, but you will not be identified by name.

3. Provision of free treatment for research related injury. Not applicable (no chance of any injury)

4. Compensation of subjects for disability or death resulting from such injury: Not Applicable (no chances of any study related disability or death)

5. Freedom of individual to participate and to withdraw from research at any time without penalty or loss of benefits to which the subject would otherwise be entitled.

6. You have complete freedom to participate and to withdraw from research at any time without penalty or loss of benefits to which you would otherwise be entitled.

7. Your participation in the study is optional and voluntary.

8. The copy of the results of the investigations performed will be provided to you for your record, if you wish.

9. You can withdraw from the project at any time, and this will not affect your subsequent medical treatment or relationship with the treating physician.

10. Any additional expense for the project, other than your regular expenses, will not be charged from you.

Details of the candidate with phone number: Dr.U.Anushaprasath,

PG Anaesthesiology & Critical Care

AIIMS Jodhpur

7010973507.

à¤ªà¤°à¤¿à¤¶à¤¿à¤·à¥à¤Ÿ 2

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   Appendix -3

PROFORMA

S.No.â€‹â€‹     Date:

Thesis Title: Evaluation of predictive performance of sonographic airway assessment parameters and comparison of their efficacy to predict difficult airway with clinical airway predictors:

A Cross sectional study

IPD Serial no/Sticker:

Age/Sex: Weight: (kg) Height :(cm) BMI:

ASA status: Co-Morbidities

History of OSA Yes/ No

Preoperative Clinical Airway assessment:

Mouth opening (inter-incisor gap) : >2Cm/ <2Cm

Neck movements : Adequate/Inadequate â–¡

Modified Mallampatti grade : Grade 1 â–¡, Grade 2 â–¡, Grade 3â–¡, Grade 4 â–¡

Jaw protrusion/ Upper lip bite test : Class 1 â–¡, Class 2 â–¡, Class 3 â–¡

Thyromental distance :    cm

Mentohyoid distance :    cm

Neck circumference at the level of larynx :      cm

Preoperative Sonographic Airway assessment:

Hyomental distance in neutral head position (HMDN):

Hyomental distance extended head position (HMDE):

Hyomental distance Ratio (HMDN/HMDE) :

Hyoid bone visibility :

Tongue parameters

Width: Volume: Cross sectional area:

Anterior neck soft tissue thickness at the level of:

Epiglottis       Hyoid     Vocal cords

(Skin to epiglottis at the level of THM) (Skin to hyoid) (Skin to vocal cords)

Pre E (Skin to epiglottis distance) /EVC (distance from the epiglottis to the midpoint of the vocal cords) ratio

Mandibular condylar mobility

Time taken for scanning:

Cormack- Lehane grade

Intubation difficulty Scale:

| | | |

| --- | --- | --- |

|

S.No

Parameters

Score

|

1

Number of intubation attempts > 1

|

2

Number of operators > 1

|

3

Number of alternative intubation techniques used

|

4

Glottic exposure

|

5

Lifting force required during laryngoscopy

|

6

Necessity for external laryngeal pressure

|

7

Position of the vocal cords at intubation

|

Total score

â€¢ IDS score 0- Easy intubation

â€¢ IDS score >0, < 5- slight difficulty

â€¢ IDS score > 5- moderate to major difficulty

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 130

Inclusion Criteria

Patients in the age group of 18- 60 years, undergoing elective surgical procedures, which require intubation and neuromuscular blockade.

Exclusion Criteria

Exclusion criteria 1.
Known tongue, oropharyngeal, laryngeal, or head and neck cancers, tumors, or anatomy-altering conditions 2.
Any notable swelling, scarring, cysts; ongoing infections in the mouth, head, or neck.
Facial fractures 4.
Cervical spine fracture/ instability 5.
Inability to insert Macintosh blade in the oral cavity for laryngoscopy 6.
Full stomach/ emergency intubations/ altered levels of consciousness 7.
Tracheostomised patients 8.
Refusal or inability to give consent.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness of sonography based airway assessment parameters as predictors of difficult laryngoscopy and intubation using Cormackâ€“Lehane (CL) grade and intubation difficulty scale respectively	During intubation

Secondary Outcome Measures

Name	Time	Method
Simultaneous evaluation of predictive ability of clinical airway predictors	During intubation
Comparison of efficacy of clinical and sonographic airway parameters as tools of predicting difficult airway	During intubation
Possible development of a model for prediction of difficult airway	During intubation

Trial Locations

Locations (1): AIIMS Jodhpur
🇮🇳
Jodhpur, RAJASTHAN, India
AIIMS Jodhpur
🇮🇳Jodhpur, RAJASTHAN, India
Dr U Anushaprasath
Principal investigator
7010973507
anushaprasath18@gmail.com