| CTRI Number |
CTRI/2024/04/066451 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Measurements of distances in participants such a skin to hyoid bone and skin to thyroid isthmus with the help of ultrasound.Main outcome of the study to predict difficult airway.It is a noninvasive prospective observational study. |
|
Scientific Title of Study
|
Ultrasonographic Measurements of Distances from Skin to Hyoid Bone and Skin to Thyroid Isthmus as Predictors of Difficult Airway- A Prospective Observational 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 |
Sushma M Sindgi |
| Designation |
Post Graduate Student |
| Affiliation |
SDM college of medical sciences and hospital,Manjushree nagar Sattur Dharwad Karnataka India 580009. |
| Address |
Shri Daneshwari Krupa, Opposite Basaveshwar circle, Vidyanagar Sindgi 586128.Karnataka India.
Dharwad
KARNATAKA
586128
India |
| Phone |
9535121919 |
| Fax |
|
| Email |
sushsindagi1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Agnihotri |
| Designation |
Associate Professor |
| Affiliation |
SDM college of medical sciences and hospital,Manjushree nagar Sattur Dharwad Karnataka India 580009. |
| Address |
Department of Anaesthesiology
SDM College of Medical Sciences
and Hospital, Manjushree Nagar Sattur. Dharwad katakana India 580009.
Dharwad
KARNATAKA
580009
India |
| Phone |
9986066030 |
| Fax |
|
| Email |
docshilpa04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satish Shankar Kelageri |
| Designation |
Senior Resident |
| Affiliation |
SDM college of medical sciences and hospital,Manjushree nagar Sattur Dharwad Karnataka India 580009. |
| Address |
Department of Anaesthesiology,
SDM College of Medical Sciences
and Hospital, Manjushree Nagar Sattur. Dharwad India 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
8970603987 |
| Fax |
|
| Email |
satishkelageri46@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Medical Sciences and Hospital, Manjushree Nagar Sattur,Dharwad Karnataka India 580009 |
|
|
Primary Sponsor
|
| Name |
Sushma M Sindgi |
| Address |
Shri Daneshwari Krupa, Opposite Basaveshwar Circle.Vidyanagar,Sindgi 586128 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sushma M Sindgi |
SDM hospital |
SDM College of Medical Sciences and Hospital, Manjushree Nagar sattur, Dharwad Karnataka India 580009.
Department of Anaesthesiology
Dharwad
KARNATAKA |
9535121919
sushsindagi1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee SDM medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgeries under general anaesthesia.
2.ASA physical status 1,2,3.
3.Patient aged 18-70 years.
4.No upper airway deformity, tumor, trauma. |
|
| ExclusionCriteria |
| Details |
1.Modified anaesthesia protocol or cancellation of endotracheal intubation.
2.Patients with oro-facial trauma or deformity. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the accuracy of preoperative ultrasound measurements namely,
1.Distance from skin to hyoid bone(DSHB).
2.Distance from skin to thyroid isthmus(DSTI).
In identifying patients with difficult airway. |
Outcome will assessed at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing ultrasonographic anatomy with other existing methods like Thyromental distance & Sternomental distance. |
Outcome will be assessed at baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/05/2024 |
| 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
|
Airway management is an important part of any patient undergoing a surgical procedure. Unanticipated difficult airway in patients is associated with lot of potential risk for the safety of the patient and remain a challenge for anaesthesiologist. upper airway Ultrasonography may help us because it requires less patient cooperation than the already existing methods like Thyromental distance and Sternomental distance. It also adds to the value of old methods by improving the accuracy of prediction of difficult airway when used together. |