| CTRI Number |
CTRI/2025/07/090852 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of ultrasound to measure airway structures for predicting difficult laryngoscopy in patients undergoing surgery |
|
Scientific Title of Study
|
Evaluation of skin to epiglottis distance, tongue thickness and hyomental distance by airway ultrasound for predicting difficult laryngoscopy: A prospective observational study. |
| 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 Bhumika Gautam |
| Designation |
PGJR1 |
| Affiliation |
Government Institute of Medical Sciences, Greater Noida |
| Address |
Department of Anesthesia, First floor, Ot complex, Government Institute of Medical Sciences, Kasna, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201312 India |
| Phone |
9045441801 |
| Fax |
|
| Email |
bhumikagautam123@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nazia Nazir |
| Designation |
Professor & Head |
| Affiliation |
Government Institute of Medical Sciences, Greater Noida |
| Address |
Department of Anesthesia, First floor, Room no.2046, Ot complex, Government Institute of Medical Sciences, Kasna, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201310 India |
| Phone |
9560102957 |
| Fax |
|
| Email |
nazunazir@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhumika Gautam |
| Designation |
PGJR1 |
| Affiliation |
Government Institute of Medical Sciences, Greater Noida |
| Address |
Department of Anesthesia, First floor, Ot complex, Government Institute of Medical Sciences, Kasna, Greater Noida
Gautam Buddha Nagar UTTAR PRADESH 201312 India |
| Phone |
9045441801 |
| Fax |
|
| Email |
bhumikagautam123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Medical Sciences,
near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh, 201310, India. |
|
|
Primary Sponsor
|
| Name |
Government Institute of Medical Sciences |
| Address |
Near Gautam Buddha University, kasna village, Greater Noida, Uttar Pradesh, 201310, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhumika Gautam |
Government Institute Of Medical Sciences |
Near Gautam Buddha University (Delhi NCR, Kasna Village, Greater Noida, Uttar Pradesh 201310 Gautam Buddha Nagar UTTAR PRADESH |
9045441801
bhumikagautam123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-60 years, classified as ASA I,II,III scheduled for elective surgeries under general anaesthesia that require endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Those posted for emergency surgeries
Patients with airway abnormalities, airway trauma, or conditions like retrognathis, macroglossia or beard that could interfere with airway assessment
Neck scarring, swelling, burns, limited neck mobility, or a history of neck surgery
Those not providing written informed consent and other concurrent conditions such as cervical spine trauma, thyroid goitre, tracheal stenosis etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the predictive value of airway ultrasound measurements (combination of skin to epiglottis distance, tongue thickness and hyomental distance) for difficult laryngoscopy with Cormack-Lehane grading.
|
5mins, 10 mins, 20mins, 30mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the predictive value of airway ultrasound measurements with traditional
clinical parameters (modified Mallampati grading, neck circumference and hyomental
distance) for difficult laryngoscopy with Cormack-Lehane grading. |
5 mins, 10 mins, 20 mins, 30 mins |
To compare the predictive value of airway ultrasound measurements with traditional
clinical parameters (modified Mallampati grading, neck circumference and hyomental
distance) for difficult laryngoscopy with Cormack-Lehane grading. |
5 mins, 10 mins, 20 mins, 30 mins |
|
|
Target Sample Size
|
Total Sample Size="82" Sample Size from India="82"
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)
|
01/08/2025 |
| 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="1" 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
|
The primary responsibility of the anesthesiologist is to provide adequate oxygenation and ventilation to the patient by securing the airway. 1
An unanticipated situation of “Cannot Intubate Cannot Oxygenate” is most dreaded among the anesthesiologists. These events mainly pertain to failure of maintaining patent airway. To prevent such untoward events, many methods have been introduced to identify who can be easily intubated or not. 2
Difficulty in airway management is a significant cause of morbidity and mortality in anesthesia, intensive care, and emergency medicine practice. Recognizing patients at risk of difficult tracheal intubation is essential, especially in patients with apparently normallooking airways. Difficult laryngoscopy (DL) is considered a surrogate indicator of difficult intubation. 3
However, every once in a while, an anesthesiologist encounters an unanticipated difficult intubation, which leads to stressful clinical situations, especially in resourcepoor highvolume centres. The incidence of DL ranges between 1.5 and 13%, and the primary goal of the anesthesiologists is to recognize the difficult airway (DA) and to reduce or eliminate potential risks linked to its precise management. 3
Ultrasound has also emerged as a promising tool for airway assessment and management due to its familiarity, accessibility, safety, and non-invasive nature. It can assist physicians in identifying relevant anatomy with objective measurements of airway parameters and guiding airway interventions with dynamic real-time images. 4
This study aims to ultrasonographically assess the soft tissue thickness preoperatively based on three parameters-skin to epiglottis distance, tongue thickness and hyomental distance and find out whether these parameters can predict a difficult airway in adults. |