| CTRI Number |
CTRI/2023/06/054415 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparision of physical and ultrasound parameters to predict difficulty in laryngoscopy |
|
Scientific Title of Study
|
Prediction of difficult laryngoscopy by ultrasound quantification of Anterior neck soft tissue and pretracheal tissue : An observational analytical 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 |
Lakshmi Kamala Narra |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Anaesthesia Office ,Department of Anaesthesiology and Critical care ,Old Block ,2cd Floor ,Jawaharlal Institute of Postgraduate Medical Education and Research ,Gorimedu ,Pondicherry, PIN-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8309967837 |
| Fax |
|
| Email |
lakshmi.kamala3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMVS Satya Prakash |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Anaesthesia Office ,Department of Anaesthesiology and Critical care ,Old Block ,2cd Floor ,Jawaharlal Institute of Postgraduate Medical Education and Research ,Gorimedu ,Pondicherry, PIN-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786184626 |
| Fax |
|
| Email |
munaganuri1975@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Lakshmi Kamala Narra |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Anaesthesia Office ,Department of Anaesthesiology and Critical care ,Old Block ,2cd Floor ,Jawaharlal Institute of Postgraduate Medical Education and Research ,Gorimedu ,Pondicherry, PIN-605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8309967837 |
| Fax |
|
| Email |
lakshmi.kamala3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia Office ,Department of Anaesthesiology and Critical care ,Old Block ,2cd Floor ,Jawaharlal Institute of Postgraduate Medical Education and Research,Gorimedu ,Pondicherry, PIN-605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research CAMPUS , DHANAVNTARI NAGAR , PUDUCHERRY , PIN :605006 |
| 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 |
| DrLakshmi Kamala Narra |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Jipmer campus road , Dhanavantari nagar , Puducherry ,605006
Pondicherry
PONDICHERRY |
8309967837
lakshmi.kamala3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee for observational studies DHR REG.NO. EC /NEW/INST/2020/331 |
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 |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III
Undergoing surgery with endotracheal tube |
|
| ExclusionCriteria |
| Details |
Patients with
1.Facial fractures or trauma
2.Cervical spine instability
3.Pregnancy
4.Difficulty in positioning for intubation
5. Difficulty in performing ultrasound assessment
6.Patients in whom Rapid sequence induction is contraindicated. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| predictive accuracy of different USG measurements of anterior neck soft tissue and physical parameters for level of difficulty in laryngoscopy |
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relationship between different USG measurements and physical parameters with conventional clinical screening tests to predict difficult laryngoscopy.
|
11months |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
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)
|
04/07/2023 |
| 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
|
Airway management is considered to be the most important step during any medical management especially anaesthetic management. Difficulty in airway management is a major cause of morbidity and mortality in anaesthetic practice. Preoperative assessment of airway and predicting the possibility of difficult laryngoscopy and intubation can be useful to avoid undesirable complications.Anaesthetist have been to trained to predict the difficulty of laryngoscopy by anatomical features. Ultrasound Studies predicting the accuracy of USG quantification of anterior neck soft tissue and pretracheal tissue for the level of difficulty in laryngoscopy are inadequate. In situations where patient is unconscious and non- cooperative clinical screening tests play minimal role in predicting difficult laryngoscopy .In emergency conditions where time is an important factor MRI and CT scan cannot be done, usage of portable ultrasound might be helpful to diagnose difficult airway rapidly. Studies comparing the accuracy of different USG parameters in predicting difficult laryngoscopy are inadequate. The proposed study included the physical parameters, USG parameters Skin to anterior commissure distance and pretracheal tissue thickness also to assess its predictive accuracy in comparison with skin to hyoid distance, skin to thyrohyoid membrane distance.
|