| CTRI Number |
CTRI/2025/11/097195 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Ultrasound vs Mallampati Grading for Predicting Difficult Airway: A Prospective Observational Study |
|
Scientific Title of Study
|
A Prospective Observational Study On The Comparison Of Ultrasound Parameters
Versus Mallampathi Grading In Assessment Of Difficult Airway Laryngoscopy And
Intubation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSaniya Jabbar |
| Designation |
Post-graduate |
| Affiliation |
Rajareshwari medical college and hospital |
| Address |
Department of Anesthesiology
Rajareshwari medical college and hospital Mysore road kambipura Banglore
KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9886442567 |
| Fax |
|
| Email |
sani08168@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmya M Jois |
| Designation |
Professor |
| Affiliation |
Rajareshwari medical college and hospital |
| Address |
Department of Anesthesiology
Rajareshwari medical college and hospital,Mysore road kambipura Banglore
KARNATAKA
Rajareshwari medical college and hospital Mysore road kambipura Banglore
Bangalore
KARNATAKA
560074
India |
| Phone |
9980891082 |
| Fax |
|
| Email |
drsowmyasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmya M Jois |
| Designation |
Professor |
| Affiliation |
Rajareshwari medical college and hospital |
| Address |
Department of Anesthesiology
Rajareshwari medical college and hospital,Mysore road kambipura Banglore
KARNATAKA
Rajareshwari medical college and hospital Mysore road kambipura Banglore
Bangalore
KARNATAKA
560074
India |
| Phone |
9980891082 |
| Fax |
|
| Email |
drsowmyasharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical College and Hospital,Mysore Road,Kambipura,Bangalore Bangalore
KARNATAKA 560074 India |
|
|
Primary Sponsor
|
| Name |
Saniya Jabbar |
| Address |
Rajarajareshwari Medical College and Hospital Mysore road Kambipura Banglore Karnataka 560074
|
| Type of Sponsor |
Other [Self] |
|
|
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 Saniya Jabbar |
RajaRajeswari medical college and hospital |
2nd floor hospital
building,department of
Anaesthesiology,Rajara
jeswari medical college
and hospital,kambipura
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9886442567
sani08168@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R938||Abnormal findings on diagnostic imaging of other specified body structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Adult patients (18 years or older) scheduled for elective surgery under general anesthesia.
2. Airway Health: No history of significant airway anomalies such as obstructive sleep apnea, neck trauma, or tumors.
3. Normal Physical Examination: No obvious swelling, masses in the neck, or tracheal deviation.
4. Informed Consent: Willing to participate in the study and provide informed consent for ultrasound and clinical airway assessment.
5. ASA Classification: ASA I to III (healthy to moderately ill patients).
|
|
| ExclusionCriteria |
| Details |
1. Patients with anticipated difficult airways based on known risk factors (e.g., limited mouth opening, macroglossia).
2. Patients with significant congenital or acquired airway abnormalities (e.g., cleft lip/palate, tumors, tracheal stenosis).
3. Pregnant patients, due to anatomical changes that may alter airway management and ultrasound imaging.
4. Patients with altered mental status or who are unable to provide informed consent.
5. Patients with severe cardiovascular or respiratory diseases (e.g., ASA IV or V classification) that may complicate airway management.
6. Patients requiring emergency surgery where preoperative airway assessment is not feasible.
7. Patients with contraindications to ultrasound, such as skin infections or other local issues that may interfere with proper scanning.
8. Patients with cervical spine deformity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the predictive accuracy of ultrasound-based airway assessment i.e skin to epiglottis
distance with the conventional Mallampati grading for predicting difficult endotracheal
intubation in patients undergoing general anaesthesia after 24 months |
To compare the predictive accuracy of ultrasound-based airway assessment i.e skin to epiglottis
distance with the conventional Mallampati grading for predicting difficult endotracheal
intubation in patients undergoing general anaesthesia.The outcome will be assesed after 24 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the role of ultrasound in assessing specific airway parameters - tongue thickness, skin to epiglottis distance, thyromental distance, & hyomental distance (in both neutral & extended neck positions) - & to determine their predictive value in identifying difficult laryngoscopy & intubation.
|
The outcome will be assessed after 24 months. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
25/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To compare the accuracy of ultrasound-based airway assessment (skin to epiglottis distance) with Mallampati grading in predicting difficult endotracheal intubation in patients undergoing general anaesthesia. Additionally, to assess the role of ultrasound in measuring specific airway parameters such as tongue thickness, skin to epiglottis distance, thyromental distance, and hyomental distance (in neutral and extended neck positions), and to evaluate their predictive value for difficult laryngoscopy and intubation |