| CTRI Number |
CTRI/2025/07/090562 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting difficult airway using ultrasound and clinical airway assessment parameters. |
|
Scientific Title of Study
|
Evaluation of predictive ability of sonography based airway assessment parameters and clinical parameters as predictors of difficult laryngoscopy and intubation: An Observational Clinical 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 Vishakha Sinsinwal |
| Designation |
Second Year Anaesthesia Resident |
| Affiliation |
Sir Sayaji Rao Gaekward Hospital |
| Address |
SIR SAYAJI RAO GAEKWARD HOSPITAL, ANANDPURA, VADODARA, GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
9974314808 |
| Fax |
|
| Email |
vishakhasinsinwal11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Lalchandani |
| Designation |
Professor |
| Affiliation |
Sir Sayaji Rao Gaekward Hospital |
| Address |
SIR SAYAJI RAO GAEKWARD HOSPITAL, ANANDPURA, VADODARA, GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
9274586809 |
| Fax |
|
| Email |
lalchandanikavita@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishakha Sinsinwal |
| Designation |
Second Year Anaesthesia Resident |
| Affiliation |
Sir Sayaji Rao Gaekward Hospital |
| Address |
SIR SAYAJI RAO GAEKWARD HOSPITAL, ANANDPURA, VADODARA, GUJARAT
Vadodara
GUJARAT
390001
India |
| Phone |
9974314808 |
| Fax |
|
| Email |
vishakhasinsinwal11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaethesiology, SSG Hospital, Vadodara, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Sir Sayaji Rao Gaekward Hospital |
| Address |
SIR SAYAJI RAO GAEKWARD HOSPITAL, ANANDPURA, VADODARA, GUJARAT - 390001 |
| 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 Vishakha Sinsinwal |
SSG Hospital |
C - Operation Theatre, Department of General Surgery, 2nd floor, New Surgical Block, SSG Hospital, Anandpura, Vadodara - 390001
Vadodara
GUJARAT |
9974314808
vishakhasinsinwal11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research (IECBHR), VADODARA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients willing and giving consent for the procedure.
2.Patients posted for Elective Surgeries under Department of General Surgery SSG Hospital requiring Endotracheal Tube pacement.
3.Patients conformed to American Society of Anaesthesiologist (ASA) physical status Grade I, II, III in preoperative assessment. |
|
| ExclusionCriteria |
| Details |
1.Patients with past history of difficult laryngoscopy or difficult intubation.
2.Pregnant women.
3.Obese patients with Basal Metabolic Index of 40 or higher.
4.Patients with noticeable swelling in the neck region.
5.Patients with maxillofacial anomalies.
6.Patients with history of burns and neck skin contracture. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to determine the predictive ability of sonography-based airway assessment parameters as predictors of difficult laryngoscopy and intubation using POGO score (percentage of glottic opening) and intubation difficulty scale (IDS) |
Till 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome is to determine the predictive ability of clinical airway predictors & to evaluate the efficacy in terms of specificity & sensitivity of clinical & sonographic airway parameters for predicting difficult laryngoscopy & difficult intubation. |
Till 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
20/07/2025 |
| 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
|
Routine preoperative airway assessment aids in the proper management of difficult airway conditions. Clinical screening tests used routinely in airway assessment lack adequate sensitivity and specificity for detecting difficult laryngoscopy. Ultrasound is a non-invasive procedure and allows real-time visualization of anatomical structures, aiding in rapid assessment. It helps gauge parameters like airway patency, identify potential obstructions, and assess the position of vocal cords. This dynamic imaging enhances decision-making during interventions such as intubation through optimal preparation involving appropriate choice of equipment before managing airway.
In this study we aim for comprehensive use of ultrasound airway parameters along with clinical airway parameters in airway management through Clinical parameters: 1.MO - Mouth opening 2.MMG - Modified Mallampati grade 3.ULBT - upper lip bite test 4.TMD - thyromental distance 5.MHD - myohyoid distance 6.NC - neck circumference,
and sonography based parameters: 1.HMDN - hyomental distance neutral neck 2.HMDE - hyomental distance extended neck 3.TW - tongue width 4.TT - tongue thickness 5.SED - skin to epiglottis distance 6.SVC - skin to vocal cords distance 7.ANS TM - anterior neck soft tissue distance at level of thyrohyoid membrane 8.ANS Hyoid bone - anterior neck soft tissue distance at level of hyoid bone
and POGO score (Percentage of glottic opening) on direct laryngoscopy and IDS (Intubation Difficulty Scale) as key metrics. |