| CTRI Number |
CTRI/2024/06/069097 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
Use of ultrasound in difficult laryngoscopy |
|
Scientific Title of Study
|
Comparison of airway ultrasound and clinical parameters to predict difficult laryngoscopy in Emergency Department a prospective cross sectional 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 Shubhada Kadadi |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Emergency Medicine, Ground floor,AVBRH building,Sawangi Meghe.
Wardha
MAHARASHTRA
442107
India |
| Phone |
8762824650 |
| Fax |
|
| Email |
shubhadakadadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charuta P Gadkari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Emergency Medicine,Ground floor,AVBRH building,Sawangi Meghe.
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823017279 |
| Fax |
|
| Email |
charutagadkari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charuta P Gadkari |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Emergency Medicine,Ground floor,AVBRH building,Sawangi Meghe.
Wardha
MAHARASHTRA
442107
India |
| Phone |
9823017279 |
| Fax |
|
| Email |
charutagadkari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research (DMIHER),Sawangi Meghe,
Wardha(India)
Pin code:442107 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research DMIHER |
| Address |
Datta Meghe Institute of Higher Education and Research(DMIHER)
Sawangi Meghe Wardha(India)
Pin code:442107 |
| Type of Sponsor |
Private 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 Shubhada Kadadi |
Jawaharlal Nehru Medical College ( JNMC ) |
Department of Emergency Medicine,ShaliniTai Meghe Superspeciality Centre,AVBRH Campus Sawangi(Meghe)Wardha 442107
Wardha
MAHARASHTRA |
8762824650
shubhadakadadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cormack Lehane grading |
Cormack-Lehane grading on direct Laryngoscopy |
| Intervention |
Ultrasound of airway |
Skin to epiglottis distance and tongue thickness measurement by Ultrasound.
Frequency is one per patient. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
- Patients aged 18 years and above
- Patients requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
-Inability to obtain informed consent
-Patients with limited mouth opening,head and neck pathologies
-Patients with upper airway anatomical anomaly,trauma or Tumor
-Tracheostomised patients
-Patients with limited neck extension
-Pregnant patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Airway ultrasound before laryngoscopy in Emergency Department. |
Outcome assessed at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="2"
Months="0"
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
|
Effective airway management is crucial for patients in critical conditions, however it remains a challenge in Emergency. This study helps to assess the accuracy of clinical parameters, ultrasonographic upper airway parameters and laryngoscopic grade using Cormack Lehane classification to predict difficult laryngoscopy in Emergency Department. This will be a interventional study conducted in AVBRH Wardha, through clinical parameters like LEMON criteria, ultrasound measurements like skin to epiglottis distance, tongue thickness and Cormack Lehane classification on direct laryngoscopy as key metrics. |