| CTRI Number |
CTRI/2018/11/016352 [Registered on: 15/11/2018] Trial Registered Prospectively |
| Last Modified On: |
14/11/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound for studying the upper part of the breathing system to predict difficulty in seeing the opening of the voice box during administration of general anaesthesia |
|
Scientific Title of Study
|
Sonographic upper airway evaluation for prediction of difficult laryngoscopy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jamuna M |
| Designation |
PG Resident |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9632187634 |
| Fax |
|
| Email |
jamuna.m.g@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tejesh CA |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9886481848 |
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tejesh CA |
| Designation |
Professor |
| Affiliation |
MS Ramaiah Medical College |
| Address |
Department of Anaesthesiology
MS Ramaiah Medical College
Bangalore
Bangalore KARNATAKA 560054 India |
| Phone |
9886481848 |
| Fax |
|
| Email |
drtejeshca@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MS Ramaiah Medical College and Hospitals
New BEL road
MSRIT post
Bangalore-560054 |
|
|
Primary Sponsor
|
| Name |
MS Ramaiah Medical college and Hospitals |
| Address |
New BEL Road
MSRIT Post
Bangalore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Jamuna M |
Department of Anaesthesiology
MS Ramaiah Medical College
Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jamuna M |
MS Ramaiah Medical Teaching Hospital |
Department of Anaesthesiology
2nd floor
MSRMTH
New BEL Road Bangalore KARNATAKA |
9632187634
jamuna.m.g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee MS Ramaiah Medical College and Hospitals |
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 |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled to undergo elective surgery under general anaesthesia categorised as American Society of Anaesthesiologists (ASA) Grade I and II
|
|
| ExclusionCriteria |
| Details |
Patients with:
Interincisor gap < 3cm
Edentulous patients / partial dentition
Maxillofacial abnormalities
Restricted neck movements
Cervical tumors or goiter
Oropharyngeal pathology
Cervical spine instability
Pregnancy
History of difficult laryngoscopy or intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prediction of difficult laryngoscopy in terms of Cormack Lehane Grading system |
During laryngoscopy five minutes after induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="226" Sample Size from India="226"
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)
|
15/12/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Airway
management is one of the critical skills mastered by anaesthesiologists and it
is their prime responsibility. Suboptimal airway management is a major cause of
patient morbidity and mortality. Unanticipated difficult
laryngoscopy and intubation remains one of the most important concerns and
challenges in routine anaesthesia practice. Accurate airway assessment may
reduce the number of unanticipated difficult laryngoscopy and intubation, as
well as enable modification of initial airway management plan. The currently employed routine clinical airway assessment parameters when used
alone or in combination are however unable to predict difficult laryngoscopy
and intubation with satisfactory sensitivity and specificity.
Ultrasound
machines are now widely available in operating rooms and is becoming an
inherent part of anaesthesiologist’s armamentarium for vascular access and
regional anaesthesia. Ultrasound is safe, non-invasive, portable, easily
reproducible and gives real time images. Sonography has been used for airway
assessment and has been evolving as a useful tool for this purpose. Encouraging
results have been obtained in few studies utilising the sonographic parameters
for assessment of airway. However, there are no established
standard sonographic parameters to predict difficult laryngoscopy. Hence, the
present study is designed to evaluate any correlation between sonographically
assessed parameters and the grade of difficulty at direct laryngoscopy. |