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CTRI Number  CTRI/2021/12/038781 [Registered on: 21/12/2021] Trial Registered Prospectively
Last Modified On: 12/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A scan to measure distance between tongue and palate to assess difficuty in holding oxygen mask during anaesthesia-an observational study. 
Scientific Title of Study   Ultrasound measurement of palatoglossal space and tongue thickness to predict difficult mask ventilation-an observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mohan VK 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Department of Anesthesiology and critical care, JIPMER, Pondicherry.

Pondicherry
PONDICHERRY
605006
India 
Phone  9841546265   
Fax    
Email  drmohanvk@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SARATH S  
Designation  junior resident  
Affiliation  JIPMER 
Address  Department of Anesthesiology and critical care, JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9159010530  
Fax    
Email  saraths00067@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SARATH S  
Designation  junior resident  
Affiliation  JIPMER 
Address  Department of Anesthesiology and critical care, JIPMER, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9159010530  
Fax    
Email  saraths00067@gmail.com  
 
Source of Monetary or Material Support  
JIPMER 
 
Primary Sponsor  
Name  JIPMER 
Address  JIPMER Dhanvantri nagar Gorimedu Pondicherry 
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 
sarath  JIPMER  Department of Anaesthesiology and Critical Care, Second floor,Room no 2 , Institute block Dhanvantri nagar
Pondicherry
PONDICHERRY 		 9159010530

saraths00067@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K358||Other and unspecified acute appendicitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusion criteria
All patients aged above 18 years posted for surgical procedures
under general anesthesia with endotracheal tube 
 
ExclusionCriteria 
Details  Exclusion criteria
1. Patients with gross facial anomalies
2. Nasal blockade
3. Facial injuries/trauma patients
4. Planned rapid sequence induction
5. Pregnancy
6. Difficulty in positioning for intubation
7. Reduced mouth opening
8. Contraindication for using non depolarizing muscle
relaxant
9. Difficulty in performing ultrasound assessment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the sensitivity and specificity of
palatoglossal space as seen by ultrasonography to
predict difficult mask ventilation. 		 One day before surgery USG measurement will be done and next day in operation theatre till intubation patient will be participating in this study 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the sensitivity and specificity of
palatoglossal space and tongue thickness as seen
by ultrasonography to predict difficult
laryngoscopy by Cormack Lehane grading
• To determine the correlation between
palatoglossal space and Modified Mallampatti
score.
 		 One day before surgery USG measurement will be done and next day in operation theatre till intubation patient will be participating in this study 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   30/12/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After obtaining approval from postgraduate research monitoring committee and ethical committee and registering in CTRI, patients satisfying the eligibility criteria will be enrolled for the study after obtaining written informed consent. Preoperative assessment will be done by the attending anesthesiologist one day before surgery. The patient’s information, medical history will be obtained. Physical examination includes height, weight, body mass index (BMI). Airway evaluation includes Modified Mallampatti score, mouth opening (fingers breath), neck extension, upper lip bite test. A flexible ruler will be used to measure airway parameters hyomental distance (cm), thyromental distance (cm), sternomental distance (cm). The patient will be explained about ultrasonography procedure and ultrsonography will be performed in sniffing postion.The space between tongue and palate will be measured by ultrasound machine (esaote My lab x5). A 1-8MHz frequency curvilinear ultrasound probe will be used to get the submandibular view, and the space between the tongue and palate will be measured in the coronal and saggital plane by placing probe at mentohyoid junction. The thickness of the tongue will be measured in saggital plane as the maximum vertical dimension from submental skin to the dorsal surface of the tongue at mentohyoidjunction.The ultrasound assessment will be done by a person who has done atleast 20 senior assisted assessments before.On the day of surgery, standard monitoring including ECG, NIBP, Pulse rate, SpO2 will be connected and monitored in the OT table. IV line will be secured. Preoxgenation for 3mintues will be done . Equipment for managing difficult airway will be kept ready. The technique of induction will be decided by the attending anesthesiologist. After induction, the patient will be paralyzed with non depolarising muscle relaxant and manual mask ventilation will be done. The mask ventilation will be done by a resident with more than one year training. Using 2 hands to hold mask, use of airway device to assist mask ventilation, using airway pressures more than 20cmH2O, increasing oxygen flow, change of operator will be noted. The difficulty in mask ventilation is graded using the grading system described by Han et al.9 Grade Description Grade 0 Mask ventilation not attempted Grade 1 Easy ventilation with mask Grade 2 Ventilated with mask using airway adjuncts Grade 3 Inadequate, unstable, requires 2 operators Grade 4 Unable to mask ventilate Grade 0 and grade 1,2 will be considered as easy, grade 3 ,4 will be considered as difficult ventilation. If the difficulty in mask ventilation was because of leak around the mask, the patient will be withdrawn from the study. Laryngoscopy will be done by a resident with more than one year training with head extended at atlanto-occipital joint by keeping head ring and neck flexed on thorax by keeping pillow under shoulder using Mcintosh curved laryngoscopy blade of size 3 or 4. During laryngoscopy, the Cormack Lehane grading will be noted. The Cormack Lehane grades 1 and 2 will be designated as easy , grades3 and 4 will be designated as difficult laryngoscopy. The Cormack-Lehane grading system –for laryngoscopic view:Grade 1 is visualization of the entire laryngeal aperture. Grade 2 is visualization of only the posterior portion of the laryngeal aperture. Grade 3 is visualization of only the epiglottis. Grade 4 is no visualization of the epiglottis or larynx. 
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