| CTRI Number |
CTRI/2021/10/037691 [Registered on: 29/10/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare a clinical method and ultrasonographic method in prediction of difficult laryngoscopy during intubation under general anaesthesia |
|
Scientific Title of Study
|
Comparison of thyromental height and ultrasound measurement of skin to epiglottis distance as predictors of difficult laryngoscopy in patients posted for elective surgery under General Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subalakshmi |
| Designation |
PG Resident |
| Affiliation |
ABVIMS DR.RML HOSPITAL |
| Address |
Department of Anaesthesia
RML Hospital
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09585743398 |
| Fax |
|
| Email |
subalakshmi72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Arora |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS DR.RML HOSPITAL |
| Address |
Rml hospital, Baba kharag singh marg, New delhi
Rml hospital Baba kharag singh marg New delhi
New Delhi
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
namitaarora16@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Subalakshmi |
| Designation |
PG Resident |
| Affiliation |
ABVIMS DR.RML HOSPITAL |
| Address |
Department of Anaesthesia
ABVIMS & DR.RML HOSPITAl
New Delhi
New Delhi
DELHI
110001
India |
| Phone |
09585743398 |
| Fax |
|
| Email |
subalakshmi72@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia ABVIMS DR RML HOSPITAL |
| Address |
Baba kharag singh marg New Delhi |
| Type of Sponsor |
Government 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 |
| Subalakshmi |
ABVIMS DR RML HOSPITAL |
Anaesthesia Department Baba kharag singh marg New delhi
New Delhi
DELHI |
09585743398
subalakshmi72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC ABVIMS RMLH 332 |
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 |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 2 3
Elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Pregnant patients
Altered anatomy like cervical fractures maxillofacial abnormalities neck swelling mass |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Thyromental height cm
2 USG guided Skin to epiglottis distance cm
3 CL Grading 1 to 4 |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Thyromental distance cm
2 Modified mallampati classification Class 1 to 4
3 Ease of measurement of TMHT DSE TMD MMC based on a Likert scale as Very easy Easy Neutral Hard Very hard
|
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
20/11/2021 |
| 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="0"
Months="9"
Days="0" |
|
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
|
Aim To compare Thyromental height and Ultrasound measurement of skin to
epiglottis distance as predictors of difficult laryngoscopy. Primary
objective To compare Thyromental height and Ultrasound measurement of skin to
epiglottis distance as predictors of difficult laryngoscopy in adult patients undergoing elective surgery
under general anaesthesia. Secondary
objective 1)To compare TMHT with thyromental distance (TMD)
and Modified Mallampati classification ( MMC) 2) To compare ultrasound measurement of DSE
with thyromental distance (TMD) and Modified
Mallampati classification ( MMC)
3)To
compare the ease of measurement
of thyromental height and ultrasound measurement of DSE by likert scale |