FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089099 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 14/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To identify difficult airway in patients undergoing general anaesthesia by assesing same physical parameter with ultrasound guided parameter  
Scientific Title of Study   Diagnostic Accuracy Of Distance From Skin To Epiglottis In Predicting Difficult Airway Using Ultrasonographic Airway Assessment 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gayathri P 
Designation  JUNIOR RESIDENT  
Affiliation  Chettinad hospital and research institute 
Address  D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam

Chennai
TAMIL NADU
603103
India 
Phone  9884607799  
Fax    
Email  gayu.jp.98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVijay Narayan  
Designation  Professor  
Affiliation  Chettinad hospital and research institute 
Address  D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam

Chennai
TAMIL NADU
603103
India 
Phone  7904535573  
Fax    
Email  vijaynarayanans@care.edu.in  
 
Details of Contact Person
Public Query
 
Name  DrVijay Narayan  
Designation  Professor  
Affiliation  Chettinad hospital and research institute 
Address  D block , 1st floor,Department of Anaesthesiology,Chettinad hospital and research institute,chettinad health city,Rajiv Gandhi Salai( OMR) ,kelambakkam

Chennai
TAMIL NADU
603103
India 
Phone  7904535573  
Fax    
Email  vijaynarayanans@care.edu.in  
 
Source of Monetary or Material Support  
Chettinad hospital and research institute, chettinad health city, Rajiv Gandhi Salai,Kelambakkam, chennai, Tamilnadu, India-603103 
 
Primary Sponsor  
Name  Chettinad hospital and research insitute  
Address  Chettinad hospital and research institute, chettinad health city, Rajiv Gandhi Salai,Kelambakkam, chennai, Tamilnadu, India-603103 
Type of Sponsor  Private medical college 
 
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 Gayathri P  CHETTINAD HOSPITAL AND RESEARCH INSITUTE   D- block , 1st floor, Department of Anaesthesiology, Chettinad Health city, Chettinad health city,Rajiv Gandhi Salai, Kelambakkam,
Chennai
TAMIL NADU 
9884607799

gayu.jp.98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE ( CARE IHEC- I)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cormack lehane grading   To compare Cormack lehane grading during routine laryngoscopy to asses whether the intervention is able to assess the difficult airway preoperatively  
Intervention  Ultrasound measurement of skin to epiglottis in patients undergoing general anaesthesia   To preoperatively assess the Ultrasound measurement of skin to epiglottis in patients undergoing general anaesthesia to find out the diagnostic accuracy of the parameter (skin to epiglottis distance )in assesing difficult airway  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age: 18-65 years
ASA grade -1,2,3,4
Patients undergoing surgery under
general anaesthesia. 
 
ExclusionCriteria 
Details  Patients who denies consent
Patients with prominent features of the difficult airway with facial abnormalities
Morbid obesity (body mass index, BMI more than 35 kg/m2)
Restricted mouth opening
Cervical spine anomalies
Uncooperative and pregnant patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compute the diagnostic accuracy of distance from skin to
epiglottis through Ultrasound assessment in predicting difficult airway 
30 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To
assess the sensitivity, specificity, positive predictive value and negative predictive value of the whole study  
6 months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/06/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Diagnostic Accuracy Of Distance From Skin To Epiglottis In Predicting Difficult Airway Using Ultrasonographic Airway Assessment

 Introduction
 One of the prime responsibilities of the anesthesiologist is to provide adequate ventilation by securing the patient’s airway. Preoperative assesment of the patient’s airway facilitates to predict the difficult airway The diagnostic precision of a pre-anesthetic airway checkup in predicting difficult intubation is very low, and unpredicted difficult intubations persist. The diagnostic accuracy of these pre-anesthetic airway screening parameters has varied results in various studies. Recently, ultrasound (USG) guided airway assessment is showing encouraging results. However, few research studies have studied the role of ultrasonographic measurements in detecting difficult airways preoperatively.
 The objective behind our study is to search for a simple and bedside noninvasive method to identify difficult airway As there are only less number studies predicting difficult airway using this predictor i would like to do my study with predictor for assesing diffficult airway

  OBJECTIVES 

Primary objective
  To compute the diagnostic accuracy of distance from skin to epiglottis through Ultrasound assessment in predicting difficult airway 

secondary objective  
To assess the sensitivity, specificity, positive predictive value and negative predictive value

 Study design Prospective observational study 
 Number of subjects/sample size The minimum sample size for the study has been calculated to 100 

 Study Methodology or procedure
 Inclusion criteria : Age: 18-65 years ASA grade -1,2,3,4 Patients undergoing surgery under general anaesthesia.
 Exclusion criteria : Patients who denies consent Patients with prominent features of the difficult airway with facial abnormalities Morbid obesity (body mass index, BMI more than 35 kg/m2) Restricted mouth opening Cervical spine anomalies Uncooperative and pregnant patients 

After obtaining approval from Ethics committee Informed and written consent will be obtained from all patients • PREOPERATIVE ASSESSMENT: Detailed history and physical examination, baseline data like HR,BP and basic investigations will be collected. MMP grading (1,2,3,4),Mouth opening (more or less than 3 finger breath) ,Thyromental distance(more or less than 6.5 cm) ,Hyomental distance (more or less than 3 finger breath) ,BMI (More or less than 35 Sq.cm) ,Neck circumference (more or less than 34 cm) ,Neck movements (ROM adequate or not adequate ) will be noted An IV access with 18G IV cannula will be secured for all patients. Premedication such as Tab Ranitidine 150mg and Tab Alprazolam 0.5mg given a night before surgery and 6 am on the day of surgery All patients will undergo detailed preoperative ultrasonographic evaluation. Ultrasonographic airway evaluation will be done with a linear high frequency probe. The Ultrasonographic measurement of the airway will be achieved with the patient in supine and the head and neck in the neutral position without a pillow, looking straight ahead with the mouth closed. Skin to epiglottis distance is noted. Study outcome or end points To preoperatively diagnose the difficult airway using ultrasound (skin to epiglottis distance)in patients undergoing surgery under general anaesthesia. 
 Ethical Considerations Approval from Chettinad Hospital and Research Institute IHEC (institutional human ethical committee) has been  obtained before starting the study. All participants will be informed regarding the purpose of study, benefits, procedure and confidentiality of the research study in their local language and in English. An informed and written consent will be taken from person who willing to participate in study
 
Study Duration (in Months / Years)  6 months 

 References 
 1. Agung Senapathi TG, Wiryana M, Aryabiantara IW, Ryalino C, Roostati RL. The predictive value of skin-to-epiglottis distance to assess difficult intubation in patients who undergo surgery under general anesthesia. Bali J Anaesthesiol 2020 4 46 8 

 2. Harjai M, Alam S, Rastogi S, et al. (July 15, 2023) Effectiveness and Validity of Preoperative Ultrasonographic Airway Assessment and Clinical Screening Tests to Predict Difficult Laryngoscopy: A Prospective, Observational Study. Cureus 157 e41933. DOI 10.7759 cureus.4193 3 tests in the evaluation of difficult airways preoperatively

 3. Soltani Mohammadi S, Tavakkoli A, Marashi M. Correlation between Ultrasound Measured Distance from Skin to Epiglottis and Epiglottis to Mid-Vocal Cord with Cormack-Lehane Classification for Predicting Difficult Intubation. Arch Anesth & Crit Care. 2019 6123 26

 4. Udayakumar G, Priya L, Narayanan V (July 05, 2023) Comparison of Ultrasound Parameters and Clinical Parameters in Airway Assessment for Prediction of Difficult Laryngoscopy and Intubation: An Observational Study. Cureus 15 7 e41392. DOI 10.7759 cureus.41392 
 
Close