CTRI Number |
CTRI/2024/01/061940 [Registered on: 29/01/2024] Trial Registered Prospectively |
Last Modified On: |
26/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective observational study |
Study Design |
Single Arm Study |
Public Title of Study
|
Prediction of difficult laryngoscopy by ultrasound measurement of face and neck parameters in adult patients |
Scientific Title of Study
|
PREDICTION OF DIFFICULT LARYNGOSCOPY BY ULTRASOUND MEASUREMENT OF COMBINATION OF AIRWAY PARAMETERS |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Vasanth Kumar B |
Designation |
Post Graduate Resident |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi,
New Delhi
India
New Delhi DELHI 110029 India |
Phone |
6382214916 |
Fax |
|
Email |
vasanthkumar9023@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Anjali Kochhar |
Designation |
Associate Professor |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi,
New Delhi
New Delhi DELHI 110029 India |
Phone |
9999197721 |
Fax |
|
Email |
dranjalikochhar@vmmc-sjh.nic.in |
|
Details of Contact Person Public Query
|
Name |
Anjali Kochhar |
Designation |
Associate Professor |
Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Address |
Department of Anaesthesia and Intensive care,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar, New Delhi,
New Delhi
New Delhi DELHI 110029 India |
Phone |
9999197721 |
Fax |
|
Email |
dranjalikochhar@vmmc-sjh.nic.in |
|
Source of Monetary or Material Support
|
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi 110029 |
|
Primary Sponsor
|
Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Address |
Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi 110029 |
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 |
DrVasanth Kumar B |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of anaesthesia,Vardhman Mahavir Medical College and Safdarjung Hospital,Ansari Nagar ,New Delhi New Delhi DELHI |
6382214916
vasanthkumar9023@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: R69||Illness, 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 |
Patients aged between 18-65years ,planned for elective surgery under general anaesthesia requiring endotracheal intubation |
|
ExclusionCriteria |
Details |
1.Patients with lesions of tongue and restricted mouth opening
2.Neck deformity,restricted neck movement,neck mass,burn neck contracture etc.
3.Anticipated difficult airway with planned awake intubation |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To predict difficult laryngoscopy by ultrasound measurement of combination of airway parameters (hyomental distance ratio,tongue thickness & condylar mobility)using Cormack - Lahane grading |
Baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare, ultrasound measurement of combination of airway parameters (hyomental distance ratio, tongue thickness & condylar mobility)with ultrasound measurement of single parameter of hyomental distance ratio in predicting difficult laryngoscopy. |
At the time of induction of anaesthesia |
|
Target Sample Size
|
Total Sample Size="65" Sample Size from India="65"
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)
|
26/02/2024 |
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="0" Months="6" 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
|
Airway examination is the most important component of anaesthesiologist’s pre- operative assessment and is a prerequisite for successful airway management. Repeated attempts to perform laryngoscopy or intubation can lead to lack of adequate oxygen delivery to brain and other vital organs, which can threaten patient life1 and it is the most important cause of anaesthesia related morbidity and mortality.
The most important factor in successful management of the difficult airway is thorough evaluation and identification of any possible problem. Various clinical parameters determining difficult airway are body mass index, atlanto-occipital extension, temporomandibular joint mobility, hyomental distance, neck mobility, mouth opening and the anatomical location of larynx etc.
The incidence of difficult laryngoscopy and tracheal intubation still ranges between 1.5%-13%.The inability to predict difficult airways is probably due to high inter observer variability and low predictability of commonly used airway assessment screening tests like modified Mallampati test (MMT), thyromental distance (TMD), hyomental distance (HMD) etc.
Hyomental distance is calculated in neutral head position (HMDn) and in extreme of head extension (HMDe). It is taken from anterior most bony landmark palpable on mentum to skin just above the hyoid bone. Hyomental distance ratio (HMDR) is taken as ratio of hyomentaldistance in extreme of head extension (HMDe) to hyomental distance in neutral head position (HMDn). Hyomental distance tell us about the submandibular space and hyomental distance ratio gives us an idea about the capacity to
extent atlanto-occipital joint, which is required to align oro-pharyngeal and laryngeal axis during direct laryngoscopy.
Tongue thickness (TT)assessed by ultrasound gives us an internal characteristics of patients upper airway and helps us in predicting difficult laryngoscopy
Condylar mobility assessed by ultrasound tells about the adequate mouth opening of the patient which is required for direct laryngoscopy
However ,studies are still insufficient to say that combined ultrasound measurement of hyomental distance ratio,tongue thickness and condylar mobility are the best predictors for difficult laryngoscopy
Ultrasound (USG) being a non- irradiating, non-invasive and simple to use technique is being seen as the best modality for airway evaluation in future.
Thus ,we planned a study for the prediction of difficult laryngoscopy by ultrasound measurement of combination of airway parameters .
|