| CTRI Number |
CTRI/2024/05/067123 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Skin to epiglottis distance by ultrasound in prediction difficult airway |
|
Scientific Title of Study
|
The significance of ultrasonographic skin to epiglottis distance
As a predictive measure for difficult laryngoscopy in clinical Practice 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 |
Dr Ganeshamoorthy B |
| Designation |
POSTGRADUATE |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology sri ramachandra institute of higher
education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9092129443 |
| Fax |
|
| Email |
drganeshamoorthybaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soma Ganesh Raja |
| Designation |
Associate Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology sri ramachandra institute of higher
education and research, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
9894162665 |
| Fax |
|
| Email |
drsoms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soma Ganesh Raja |
| Designation |
Associate Professor |
| Affiliation |
sri ramachandra institute of higher education and research |
| Address |
A6, Department of Anesthesiology sri ramachandra institute of higher
education and research, Ramachandra Nagar, Porur
TAMIL NADU
600116
India |
| Phone |
9894162665 |
| Fax |
|
| Email |
drsoms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Dr Ganeshamoorthy B |
| Address |
A6, Department of Anaesthesiology and Pain Medicine Sri
Ramachandra institute of higher education and research, Porur ,
Chennai 600116 |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 Ganeshamoorthy B |
Sri Ramachandra institute of higher education and research |
Room no A6, 6th floor ,
Department of
Anaesthesiology and
Pain Medicine Sri
Ramachandra institute
of higher education and
research, Porur
Chennai
TAMIL NADU |
9092129443
drganeshamoorthybaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Ramachandra institute of higher education and research, Porur, Chennai 600116 |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Requiring elective surgery under general Anesthesia |
|
| ExclusionCriteria |
| Details |
Expected difficult laryngoscopy
Indications to Awake fiberoptic intubation
Facial abnormality/ Swelling / previous wound / Dressing /oral-maxillofacial surgeries
Parturient
Need for Rapid sequence induction
Emergency surgeries
Patient refusal
Inability to give consent to the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the predictive validity of skin to epiglottis distance in predicting
difficult laryngoscopy among adults during general anesthesia |
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="299"
Sample Size from India="299"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/05/2024 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Preoperative Recognition of the difficult airway is important element in the anaesthesiology practice. The preoperative airway evaluation using clinical predictors such as modified Mallampati classification, hyomental and thyromental distance, neck movements, inter incisor distance, and neck circumference, which are usually used to predict a difficult airway. In the recent years the usefulness of ultrasound guided preoperative predictors for identifying difficult laryngoscopy have been studied. It was found that Difficult laryngoscopy to correlate with various ultrasound predicted parameters. |