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CTRI Number  CTRI/2021/10/037576 [Registered on: 26/10/2021] Trial Registered Prospectively
Last Modified On: 20/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Evaluation of ultrasound measured tongue thickness, tongue thickness- thyromental distance ratio and skin to epiglottis distance in predicting difficult laryngoscopy. 
Scientific Title of Study   Evaluation of ultrasound measured tongue thickness, tongue thickness- thyromental distance ratio and skin to epiglottis distance in predicting difficult laryngoscopy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Rastogi 
Designation  Associate professor 
Affiliation  SGPGIMS 
Address  Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW. UTTAR PRADESH India

Lucknow
UTTAR PRADESH
226014
India 
Phone  9793124468  
Fax    
Email  amit.rastogi.sgpgi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amit Rastogi 
Designation  Associate professor 
Affiliation  SGPGIMS 
Address  Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW. UTTAR PRADESH India

Lucknow
UTTAR PRADESH
226014
India 
Phone  9793124468  
Fax    
Email  amit.rastogi.sgpgi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijeet kumar 
Designation  JUNIOR RESIDENT  
Affiliation  SGPGIMS  
Address  Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW UTTAR PRADESH India
Department of Anaesthesiology , SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW. UTTAR PRADESH 2
Lucknow
UTTAR PRADESH
226014
India 
Phone  8004901609  
Fax    
Email  abhijeet56.sgpgi@gmail.com  
 
Source of Monetary or Material Support  
SGPGIMS RAIBARELI. ROAD LUCKNOW  
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute of Medical Sciences 
Address  Department of Anaesthesiology SGPGIMS LUCKNOW  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amit rastogi  Sanjay Ghandhi institute of medical sciences   Anaesthesiology faculty SGPGIMS RAIBARELI ROAD LUCKNOW
Lucknow
UTTAR PRADESH 
8004904043

amit.rastogi.sgpgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE,SGPGIMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.ASAI and ASA II PATIENTS 2. Both males and females patients age >18 yrs of age 3.patients undergoing elective surgeries under GA with ETT 
 
ExclusionCriteria 
Details  Non consenting patients,BMI >35kg/m2, H/o difficult airway
In past surgery,thyromental distance<5cm,inter incisor distance less than 2cm,restricted neck movement,maxilla facial anomalies, anatomical deformities,H/o trauma,surgery to upper airway CHANGE in Anaesthetic technique
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
prediction of difficult laryngoscopy with ultrasound measured tongue thickness, tongue thickness-thyromental distance ratio and skin to epiglottis distance.  At baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Prediction of difficult airway and difficult intubation   1 year 
 
Target Sample Size   Total Sample Size="127"
Sample Size from India="127" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/11/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Fulkerson JS, Moore HM, Anderson TS, Lowe RF Jr. Ultrasonography in the preoperative difficult airway assessment. J Clin Monit Comput. 2017 Jun;31(3):513- 530 2. 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 3. Ezri T, Gewürtz G, Sessler DI, Medalion B, Szmuk P, Hagberg C, et al. Prediction of difficult laryngoscopy in obese patients by ultrasound quantification of anterior neck soft tissue. Anaesthesia. 2003 4. Komatsu R, Sengupta P, Wadhwa A, Akça O, Sessler DI, Ezri T, et al. Ultrasound quantification of anterior soft tissue thickness fails to predict difficult laryngoscopy in obese patients. Anaesth Intensive Care. 2007 5. Wu J, Dong J, Ding Y, Zheng J. Role of anterior neck soft tissue quantifcations by ultrasound in predicting difficult laryngoscopy. Med Sci Monit. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Endotracheal intubation is one of the most important skills for anesthesiologists in
securing the airway during general anesthesia and resuscitation. Difficulties in handling airways optimally can lead to
severe adverse effects and failure can also lead to mortality. Many clinical screening tests have been used to classify
patients at risk of difficult laryngoscopy, but non have been shown to predict this complication with adequate sensitivity
and specificity. Airway sonography is a noninvasive diagnostic device for bedside visualization and measurement of
dimensions that may be linked to prediction of difficult airway management. Aims and objectives: Primary outcome
measure: Prediction of difficult laryngoscopy with ultrasound measured tongue thickness, tongue thickness- thyromental
distance ratio and skin to epiglottis distance. Secondary outcome measure: • Successful intubation • use of Adjuvants •
Time of intubation till confirmation of ETT by capnography. Material and Methods Inclusion Criteria 1. ASA I and II patients
2. Both male and female patients of age >18 years of age 3. Patients undergoing elective surgeries under GA with ETT
Exclusion Criteria Nonconsenting patients, BMI >35kg/m2 H/o difficult airway in the past surgeries Thyromental distance <
5 cm, inter incisor distance less than 2 cm, restricted neck movements. Maxillofacial anomalies/anatomical
deformities/post burn contracture/neck deformities H/o trauma, surgery to upper airway Change in anaesthetic technique.
All patients will undergo a detailed preoperative airway evaluation on the day before surgery. The modified Mallam Patti
class, mouth opening, thyromental distance, inter incisor distance will be recorded during PAC. All patients will also View undergo a detailed prospective sonographic assessment by the same anesthesiologist and Tongue thickness will be File recorded. For sonographic assessment, the patient will be made to lie in a supine position. Mouth should be closed and tip
of tongue should slightly touch incisors. Tongue should be relaxed and patient should not phonate during assessment. Curvilinear USG probe (high frequency 6-14mHz) is placed under chin in median sagittal plane and view is adjusted to visualize entire tongue clearly on screen. Maximum vertical dimension from surface of tongue to submental skin is measured and this is defined as tongue thickness. After measuring tongue thickness, skin to epiglottis distance will be measured. (method n view to be decided). The next day, the patient will be shifted to the operating room, baseline monitors of electrocardiogram, noninvasive blood pressure and pulse oximetry will be connected and values noted. direct laryngoscopy will be performed by an experienced anaesthesiologist using a curved Macintosh Blade and the Cormack- Lehane grading of Laryngoscopic view will be noted. In this study, laryngoscopy will be defined as easy if Cormack Lehane grading on Laryngoscopy was 1 or 2 and it will be defined as difficult if Cormack Lehane grading was 3 or 4. All laryngoscopies will done by a single experienced anaesthesiologist who will not be privy to preoperative ultrasound airway examination. Patients will then be intubated with an appropriate sized endotracheal tube and surgery will be allowed to proceed. At the end of the surgery, the patient will be extubated following reversal of neuromuscular blockade or shifted intubated to post operative ICU for as per indications.
 
 
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