| CTRI Number |
CTRI/2024/12/077540 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study To Predict Difficult Airway Using Ultrasonography |
|
Scientific Title of Study
|
An Observational Study On The Utility Of Point-Of-Care Ultrasound In Predicting Difficult Airway By Measuring Skin To Epiglottis Distance And Its Association With Cormack-Lehane Grading |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUMIK DAS |
| Designation |
Post Graduate Trainee |
| Affiliation |
ESI-PGIMSR, ESIC Medical College, Joka |
| Address |
Department of Anesthesiology, ESI-PGIMSR, ESIC Medical College and Hospital, Joka
Kolkata
WEST BENGAL
700104
India |
| Phone |
|
| Fax |
|
| Email |
soumikdas188@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manas Ranjan Panigrahi |
| Designation |
Professor |
| Affiliation |
ESI-PGIMSR, ESIC Medical College, Joka |
| Address |
Department of Anesthesiology, ESI-PGIMSR, ESIC Medical College and Hospital, Joka
Kolkata
WEST BENGAL
700104
India |
| Phone |
7008804278 |
| Fax |
|
| Email |
dr.manas.panigrahi@esic.nic.in |
|
Details of Contact Person
Public Query
|
| Name |
Manas Ranjan Panigrahi |
| Designation |
Professor |
| Affiliation |
ESI-PGIMSR, ESIC Medical College, Joka |
| Address |
Department of Anesthesiology, ESI-PGIMSR, ESIC Medical College and Hospital, Joka
Kolkata
WEST BENGAL
700104
India |
| Phone |
7008804278 |
| Fax |
|
| Email |
dr.manas.panigrahi@esic.nic.in |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR, ESIC Medical College, Joka, Kolkata-700104, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
ESIPGIMSR ESIC Medical College Joka |
| Address |
ESI-PGIMSR, ESIC Medical College, Joka, Kolkata-700104, West Bengal, India |
| 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 |
| Manas Ranjan Panigrahi |
ESI-PGIMSR, ESIC Medical College, Joka |
ESI-PGIMSR, ESIC Medical College, Joka, Kolkata
Kolkata
WEST BENGAL |
7008804278
dr.manas.panigrahi@esic.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of ESI-PGIMSR and ESIC Medical College, Joka, Kolkata |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
All patients scheduled for undergoing elective surgeries under general anaesthesia with tracheal intubation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Measurement of skin to epiglottis distance |
Bedside USG using Samsung MySono U6 machine with a 5-12 MHz probe at level of thyrohyoid membrane |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Non pregnant
2. Elective cases undergoing general anaesthesia and requiring endotracheal intubation
3. All ASA categories
4. Patients with written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients refusal to give consent
2. History of head and neck surgeries or trauma or stiffness
3. Patients requiring rapid sequence intubation
4. Maxillo-facial anomalies
5. Inter-incisor gap less than 3 cm
6. Patients taken for awake fibreoptic intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish a non-invasive, sensitive tool for prediction of difficult airway and to find relationship between skin to epiglottis distance and Cormack-Lehane grading |
Twelve months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see whether any relationship between skin to epiglottis distance and number of attempts at intubation exists |
Twelve months |
| To assess time taken for intubation |
Twelve months |
| To assess any complication arising out of direct laryngoscopy or during course of the study |
Twelve months |
|
|
Target Sample Size
|
Total Sample Size="249"
Sample Size from India="249"
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)
|
11/12/2024 |
| 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="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
|
The difficult airway is considered as experiencing difficulty with face mask
ventilation or difficulty with intubation of upper airway by a trained anesthesiologist.
Unpredicted difficult laryngoscopy is a challenge for any anesthesiologist, emergency
physicians and intensivists. Although there are various clinical tests for predicting a
difficult airway none of them are sensitive enough to detect difficult airway.
Cormack-Lehane grading is the closest parameter we have for deciding on the
difficulty of endotracheal intubation which can only be known after inducing the
patient, providing adequate muscle relaxant and doing direct laryngoscopy.
However with the currently existing techniques and tests we can never know the
Cormack-Lehane grading beforehand. Hence anesthesiologists were always in search
of a tool that wound predict the difficult intubation before inducing the patient. With
the advent of ultrasonography in medical field we have an opportunity to explore new
techniques which can prove to be more sensitive than the current tests. Point-of-care
ultrasound can be a quick, non-invasive bedside technique to assess the difficult
airway before inducing patient for general anesthesia.
After obtaining due permission from the institutional ethics committee and approval
of West Bengal University of Health Sciences we will collect data from at least 249
patients who are posted for elective surgery planned under general anaesthesia with
endotracheal intubation. We will also record the time taken from laryngoscopy till
cuff inflation of endotracheal tube and number of attempts and find if there is
association with ultrasonography findings.
After the collection of data from all participants, we will present statistically
significant data among the participating patients. |