| CTRI Number |
CTRI/2025/01/079529 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Combining physical exams with ultrasound to predict how hard it will be to place a breathing tube in patients with mouth or throat cancers. |
|
Scientific Title of Study
|
Use of Clinical and Ultrasonographic Parameters for Prediction of Difficult Laryngoscopy in Patients with Oral and Oro-Pharyngeal Malignancies |
| 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 Shubhdeep |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9915575859 |
| Fax |
|
| Email |
shubhdeep999@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
sgrdanaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushpreet |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia,
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah
Amritsar
PUNJAB
143001
India |
| Phone |
9876416463 |
| Fax |
|
| Email |
khushpreetkullar9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Sri Guru Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, Punjab, India. 143001 |
| 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 |
| Dr Ruchi Gupta |
Sru Guru Ram Das Institute of Medical sciences |
OT no-5, Main OT,Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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
|
| Type |
Name |
Details |
| Comparator Agent |
clinical airway assessment |
clinical airway assessment will be made following parameters preoperatively: Neck movements(Extension/Flexion), Interincisior gap, Thyromental distance.
Modified Mallampati Grading, Upper lip bite, Jaw protrusion |
| Intervention |
Ultrasonographic airway assessment |
Ultrasound measurements will be conducted in the presurgical area by two experienced
anesthesiologists using the same examination protocol. The patients will be positioned
supine with their heads in the sniffing position. Ultrasound scanning will be performed
using a technique that involves scanning in the left parasagittal and transverse planes,
moving from cranial to caudal direction. Ultrasound parameters i.e. tongue thickness
10
(TT), skin to epiglottis distance (SED) (measured at the level of the thyrohyoid
membrane), skin to hyoid distance (SHD), skin to vocal cord distance (SVC) (anterior
neck soft tissue thickness at the level of the vocal cord) will be measured and recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgery for oral and oro-pharyngal cancer
2. Patients who consent to the use of assessment methods (clinical and
ultrasonographic parameters )
|
|
| ExclusionCriteria |
| Details |
1.Previous history of head and neck surgery
2.Already tracheostomised patients or in where tracheotomy was deemed as the
primary method of airway management
3.Patients in whom laryngoscopy was not attempted (fibro-optic / flexible
videoendoscope used as primary method for intubation )
4.BMI more than 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anticipation of difficult intubation in oral and oro-pharyngeal malignancies using
clinical and ultrasonographic parameters |
from the time patient is assessed in pre recovery till the tube places |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| diagnostic accuracy of both parameters |
from the time patient is assessed in pre recovery till the tube places |
|
|
Target Sample Size
|
Total Sample Size="85"
Sample Size from India="85"
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)
|
03/02/2025 |
| 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
|
Introduction: Difficult airway management is a critical challenge for anaesthesia
providers. Failure to recognise difficult laryngoscopy can often lead to significant
morbidity and mortality in patients with oral and oro-pharyngeal malignancies. In this
study various clinical and ultrasonographic parameters will be used to anticipate
difficult airway in such patients. Aim: The aim of the study is to evaluates clinical (Modified Mallampati grading,
interincisor gap, thyromental distance, neck movements, upper lip bite, jaw protrusion)
and ultrasonographic parameters (skin to epiglottis distance, skin to hyoid bone
distance, skin to vocal cords distance, tongue thickness) to predict difficult
laryngoscopy in patients with oral and oro-pharyngeal malignancies. Methodology: Airway assessment of patients with oral and oro – pharyngeal
malignancies will be performed using clinical and ultrasonographic parameters and
ease of Cormack lehane grading Outcome/Significance: The outcome of using clinical and ultrasonographic parameters for
predicting difficult laryngoscopy in patients with oral and oro-pharyngeal malignancies
demonstrates their potential utility in enhancing preoperative risk assessment. |