| CTRI Number |
CTRI/2022/07/044138 [Registered on: 19/07/2022] Trial Registered Prospectively |
| Last Modified On: |
08/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ULTRASOUND EVALUATION OF ANTERIOR NECK SOFT TISSUE THICKNESS TO PREDICT DIFFICULT
LARYNGOSCOPY IN OVERWEIGHT
ADULT PATIENTS POSTED FOR SURGERY UNDER GENERAL
ENDOTRACHEAL ANAESTHESIA - AN
OBSERVATIONAL STUDY. |
|
Scientific Title of Study
|
ULTRASOUND EVALUATION OF ANTERIOR NECK SOFT TISSUE THICKNESS TO PREDICT DIFFICULT LARYNGOSCOPY IN OVERWEIGHT ADULT PATIENTS POSTED FOR SURGERY UNDER GENERAL ENDOTRACHEAL ANAESTHESIA - AN OBSERVATIONAL STUDY. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AJNAS AP |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.
Mysore KARNATAKA 570004 India |
| Phone |
9946165525 |
| Fax |
|
| Email |
ajnasanappara@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PROF DR ARCHANA K N |
| Designation |
PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.
Mysore KARNATAKA 570004 India |
| Phone |
|
| Fax |
|
| Email |
archanamrnm@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
PROF DR ARCHANA K N |
| Designation |
PROFESSOR |
| Affiliation |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004.
Mysore KARNATAKA 570004 India |
| Phone |
|
| Fax |
|
| Email |
archanamrnm@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| JSS MEDICAL COLLEGE AND
JSS HOSPITAL , MYSORE |
|
|
Primary Sponsor
|
| Name |
JSS MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004. |
| 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 |
| Dr AJNAS AP |
JSS MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL,MG ROAD,RAMACHANDRA AGRAHARA,MYSORE,KARNATAKA,570004. Mysore KARNATAKA |
9946165525
ajnasanappara@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 to 65 years old patients of either sex
2. BMI more than 25 kg/ m²
3. ASA physical status grade I to III |
|
| ExclusionCriteria |
| Details |
1.Patients with facial fractures
2.Maxillofacial abnormalities
3.Cervical spinal fracture
4. Arthritis,
5.Pregnancy
6. Emergency cases |
|
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
-Ultrasonographic measurement of anterior neck soft tissue thickness at 3 levels
-Distance from skin to hyoid bone (DSHB)
-Distance from skin to thyrohyoid membrane (DSTM)
-Distance from.skin to anterior commissure of vocal cord (DSAC)
and to compare and correlate the findings with Cooks modification of Cormack Lehane score in predicting difficult laryngoscopy |
-Ultrasonographic measurement of anterior neck soft tissue thickness at 3 levels 30 minutes before proposed surgery
-Distance from skin to hyoid bone (DSHB)
-Distance from skin to thyrohyoid membrane (DSTM)
-Distance from.skin to anterior commissure of vocal cord (DSAC)
and to compare and correlate the findings with Cooks modification of Cormack Lehane score in predicting difficult laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and correlate the ultrasonographic measurement of anterior neck soft tissue thickness with conventional assesment methods (Modified mallampatti score, thyromental distance, interincisor gap, sternomental distance and neck movements) in predicting difficult laryngoscopy |
5mins |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
25/07/2022 |
| 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="6" 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
|
Patients in the age group of 18 to 65 of either sex with BMI above 25 kg / m² who are undergoing elective surgery under general endotracheal anaesthesia will be enrolled for the study with written informed consent. A day before the surgery a thorough preanaesthetic evaluation and assessment of the airway is done using conventional (Modified mallampatti score, thyromental distance, interincisor gap, neck movements and sternomental distance) assesment methods. Then on the day of surgery in the preoperative room ultrasonographic measurement of anterior neck at 3levels: Distance from skin to hyoid bone(DSHB), Distance from skin to anterior commisure of vocal cord (DSAC) and Distance from skin to thyrohyoid membrane (DSTM) at midline will be performed with the patient lying in supine with head and neck in neutral position using Logiq p6 pro ultrasound system manufactured by GE health care On the day of surgery after connecting the monitors and securing intravenous lines patient is preoxygenated for 3 minutes with 100 % oxygen and premedicated with Inj. midazolam 0.1mg/kg iv and Inj.Fentanyl 1 microgram/kg iv. For intravenous induction Inj. propofol 2 mg/kg will be used. After ensuring adequate ventilation, Inj succinylcholine 1.5 mg/kg will be given to achieve adequate muscle relaxation. All laryngoscopies will be done by experienced anaesthesiologists by macintosh laryngoscope using conventional methods and cooks modification of Cormack Lehane Grading will be assessed. Time taken, number of attempts and any manipulations necessary to intubate will be noted. Modified Mallampatti classification (MMC). • Class I is visualization of soft palate,uvula, fauces, and pillars. • Class II is visualization of softpalate, uvula and fauces. • Class III is visualization of softpalate and base of uvula. • Class IV is only hard palate being visible |