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CTRI Number  CTRI/2026/01/102159 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 24/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study    
Study Design  Single Arm Study 
Public Title of Study   How Neck Size and Neck Tissue Thickness Can Help Predict Difficult Airway in Obese Patients 
Scientific Title of Study   Correlation between neck circumference and ultrasound guided measurement of anterior neck soft tissue thickness in predicting difficult laryngoscopy in obese patients. 
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 Gayatri Sasikumar 
Designation  Anaesthesia Consultant 
Affiliation  Manipal Hospital , Old Airport Road,Bangalore  
Address  Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India 
Phone  9895991939  
Fax    
Email  gayatrisasikumar11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayatri Sasikumar 
Designation  Anaesthesia Consultant 
Affiliation  Manipal Hospital , Old Airport Road,Bangalore  
Address  Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India 
Phone  9895991939  
Fax    
Email  gayatrisasikumar11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gayatri Sasikumar 
Designation  Anaesthesia Consultant 
Affiliation  Manipal Hospital , Old Airport Road,Bangalore  
Address  Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA
560017
India 
Phone  9895991939  
Fax    
Email  gayatrisasikumar11@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017 
 
Primary Sponsor  
Name  Manipal Hospital  
Address  Manjipal Hospital, Old Airport Road, Rustom BhagBangalore 560017 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
Manipal Hospital   Manjipal Hospital, Old Airport Road, Rustom BhagBangalore 560017 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ANJALA BASHEER  Manipal Hospital  Department of anaesthesia, 2nd floor,Manipal Hospital 98, HAL Old Airport Rd, Kodihalli, Bengaluru, Karnataka 560017
Bangalore
KARNATAKA 
07034617246

anjala.basheerc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Manipal Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z682||Body mass index (BMI) 20-29, adult,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients scheduled for elective surgery under general endotracheal anaesthesia.
2. Age 18 years to 70 years.  
3. ASA I- III patients.
4. BMI >/= 25 kg/m2. 
 
ExclusionCriteria 
Details  1. Patients with upper airway pathology, maxillofacial abnormality,
cervical spine instability, trauma to the face or larynx and poor
submandibular space compliance.
2. Patients posted for emergency surgeries and those requiring
rapid sequence induction of anaesthesia.
3. Pregnant women and paediatric patients.
4. Inter-incisor distance < 3 cm.
5. Previous history of difficult laryngoscopy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find a correlation between neck
circumference and USG guided anterior neck soft tissue thickness
as a predictor of difficult laryngoscopy in patients with BMI /= 25
kg/m 2 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To measure anterior soft tissue neck thickness at the level of the
hyoid, thyrohyoid membrane & anterior commissure of vocal
cord in both neutral & sniffing position.

To find correlation between above parameters & difficult
intubation. 
6months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   09/02/2026 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  
All patients posted for elective surgical procedures under general
anaesthesia requiring endotracheal intubation, who satisfy the
inclusion criteria and give a written informed consent will be recruited
to the study. 
In the preoperative period, pre-anaesthetic assessment will be done
by the primary investigator. Height (cm), weight (kg), age (in years),
body mass index (BMI) and ASA physical status will be noted for all
patients. If they satisfy the inclusion criteria, patients will be instructed
about the study procedure and a written informed consent will be
obtained. Preoperative airway assessment will be done which will
include recording the modified Mallampati classification (MMP) [
Class I -visualisation of the hard palate, soft palate, fauces, uvula and
pillars; Class II- visualisation of the hard palate, soft palate, fauces,
and uvula; Class III- visualisation of the hard palate, soft palate, and
base of uvula; Class IV- visualisation of only the hard palate.], inter-
incisor gap (distance between upper and lower incisor) in cm,
thyromental distance (in cm), sternomental distance (in cm), and neck
circumference (in cm) at mid neck just below the laryngeal
prominence with the subject sitting and facing forward with shoulder
relaxed. All measurements will be done using a standard measuring
tape by the primary investigator who will not be involved in performing
laryngoscopy and intubation. On the day of surgery, ultrasound
measurements of the airway will be done by the primary investigator
in the preoperative room, using a linear high frequency probe (8-
13Hz), with the patient lying in supine position with head and neck in
neutral position. Anterior soft tissue thickness of the neck will be
measured at three levels, the hyoid, thyroid hyoid membrane and
anterior commissure of the vocal cord. The same measurements will
then be repeated with the patient in sniffing position.
In the operating room, ASA standard monitors will be attached,
baseline vital parameters will be recorded, the patient will be
preoxygenated and induction of anaesthesia will proceed as per
standard uniform protocol. After adequate muscle relaxation(TOF=0),
direct laryngoscopy will be performed by an experienced

anaesthesiologist (&gt; 3 years) who is independent of the study and the
difficulty of laryngoscopy will be scored using the modified Cormack
Lehane grading with and without BURP ( backward upward rightward
pressure). A note will also be made of the number of attempts at
intubation, change in position or technique, and failed intubation. If
there are 3 failed attempts, alternate methods of securing the airway
will be pursued and the patient will no longer be included in the study.
Anaesthesia will proceed as per routine protocol and the patient will
be continuously monitored throughout the procedure.
The measured parameters will be subjected to statistical analysis to
find any correlation between them.
 
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