| CTRI Number |
CTRI/2021/03/032033 [Registered on: 16/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To measure airway with the help of ultrasound
|
|
Scientific Title of Study
|
Evaluation of Ultrasound based assessment of Infrahyoid airway measurements as a predictor 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 |
Soundarya Mohan |
| Designation |
Junior Resident |
| Affiliation |
Pondicherry Institute Of Medical Sciences |
| Address |
department of anaesthesia
Pondicherry institute of medical sciences
kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
6380282382 |
| Fax |
|
| Email |
drsoundaryamohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M V Vidya DA DNB |
| Designation |
Assistant Professor |
| Affiliation |
Pondicherry Institute Of Medical Sciences |
| Address |
department of anaesthesia
Pondicherry institute of medical sciences kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9585550838 |
| Fax |
|
| Email |
drmvvidya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soundarya Mohan |
| Designation |
Junior Resident |
| Affiliation |
Pondicherry Institute Of Medical Sciences |
| Address |
department of anaesthesia
Pondicherry institute of medical sciences kalapet
Pondicherry
PONDICHERRY
605014
India |
| Phone |
6380282382 |
| Fax |
|
| Email |
drsoundaryamohan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences, kalapet |
| 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 |
| DRSOUNDARYA MOHAN |
Pondicherry institute of medical sciences |
Department of Anaesthesia
Pondicherry
PONDICHERRY |
6380282382
drsoundaryamohan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient scheduled for elective surgery requiring general anaesthesia with endotracheal intubation
ASA 1-3
|
|
| ExclusionCriteria |
| Details |
ASA 4
BMI >35
Pregnant women
Cervical tumours
Maxillofacial abnormalties
Distorted airways, Edentulous patients
People who cannot give their consent
Cervical spine pathology
Patient require rapid sequence intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
outcome will be assessed at the time of intubation
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/03/2021 |
| 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="5"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway related morbidity as the result of
inability to anticipate the difficult airway remains primary concerns for the
anaesthesiologist. Inability to predict difficult airway is probably due to high inter observer
variability and low predictability of routine airway assessment test.Combination
of routine clinical screening test with various ultra sound measurements might
be reliable. USG of
upper airway provides detailed assessment of anatomical structures, and
airway pathology. The main benefit of USG in anaesthesia is the predictive power
for difficult airway measurements such as thickness of anterior soft tissue at
the level of hyoid bone,thyrohyoid membrane,anterior commissure.
This
study is aimed to evaluate the utility of ultrasound measurement of infrahyoid
airway structures in predicting difficult laryngoscopy |