| CTRI Number |
CTRI/2025/10/095831 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Ultrasound parameters versus Clinical scores in prediction of difficult airway in obese patients |
|
Scientific Title of Study
|
Comparison of Ultrasound guided airway parameters versus Simplified airway risk index score for prediction of difficult airway in obese patients 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 |
Saipriya |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences , Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
9841604196 |
| Fax |
|
| Email |
saipriya4196@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Pooja Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences , Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
9340969292 |
| Fax |
|
| Email |
pooja.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Pooja Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences , Bhopal |
| Address |
Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
Bhopal MADHYA PRADESH 462020 India |
| Phone |
9340969292 |
| Fax |
|
| Email |
pooja.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Saket Nagar,MadhyaPradesh, Bhopal-462020 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja Singh |
| Address |
Department of Anaesthesiology, AIIMS Bhopal, Saket Nagar, Bhopal, Madhya Pradesh,India,462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Saipriya |
AIIMS BHOPAL |
Modular Operation Theatre, Department of Anaesthesiology, AIIMS Bhopal Bhopal MADHYA PRADESH |
9841604196
saipriya4196@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee-Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-75 years
Either sex
Patients having body mass index more than 30
Patients undergoing surgery under general
anaesthesia |
|
| ExclusionCriteria |
| Details |
Emergency surgery
Distorted airway anatomy
Blunt or penetrating Maxillofacial
trauma
Supraglottic and glottic lesions
Grade II and III trismus
Infection, burns and anaphylaxis
leading to severe oedema and
swelling of the airway
Micrognathia
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
. To compare the accuracy of ultrasound-guided airway parameters versus simplified
airway risk index in predicting difficult laryngoscopy and intubation in obese patients
using percentage error, positive and negative predictive value |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the sensitivity, specificity & threshold cut-off for ultrasound-guided airway
parameters using the ROC-AUC curve.
2. To assess the sensitivity, specificity & threshold cut-off for Simplified airway risk
index parameters using ROC-AUC curve. |
48 weeks |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
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)
|
24/10/2025 |
| 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
|
On the day of surgery, all patients will receive an
injection pantoprazole 40 mg and injection ondansetron 4 mg for aspiration
prophylaxis in the preoperative room. After ensuring routine fasting ,all
patients were monitored using electrocardiography, non-invasive blood pressure,
pulse oximetry, and temperature monitoring on the day of the operation.
Preoxygenation will be performed for 3 min while the patient will be kept in
the ramp position. Standard anesthesia induction (propofol 2 mg.kg-1, fentanyl
2 mcg.kg-1, rocuronium bromide 0.6 mg.kg-1 intravenously) will be done. After 3
minutes of bag and mask ventilation (with or without adjunct such as oral or
nasal airway), direct laryngoscopy and intubation will be performed using an
appropriate size video laryngoscope. An Anesthesiologist with at least 3 years
of experience will perform laryngoscopy and intubation.
Laryngoscopy and intubation difficulty level for both
clinical assessment using (SARI) score and ultrasound assessment of airway will
be validated against Intubation Difficulty Scale. The IDS score is the sum of
these seven parameters viz: (1) Number of attempts, (2) Number of additional
operators, (3) Alternative techniques, (4) Cormack-Lehane grade, (5) Lifting
force, (6) External laryngeal pressure, (7)vocal cord mobility. The score
interpretation 0: Easy intubation, 1-5: slightly difficult
intubation,>5:moderate to major difficulty. |