| CTRI Number |
CTRI/2023/08/055927 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective observational study for estimating the point of fixation of endotracheal tube using ultrasound and clinical parameters (5-point auscultation) in Indian population |
|
Scientific Title of Study
|
Prospective observational study for estimating the optimal Depth of
insertion of endotracheal tube in orotracheal Intubation using
ultrasound and clinical parameters (5-Point auscultation) in Indian
population at tertiary care Hospital |
| 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 Shrikanta Oak |
| Designation |
Professor |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Anaesthesiology
Seth GSMC and KEM Hospital
Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9324134023 |
| Fax |
|
| Email |
Shrikanta_oak@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shrikanta Oak |
| Designation |
Professor |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Anaesthesiology
Seth GSMC and KEM Hospital
Parel Mumbai
MAHARASHTRA 400012 India |
| Phone |
9324134023 |
| Fax |
|
| Email |
Shrikanta_oak@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sharayu Parode |
| Designation |
Junior Resident |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Anaesthesiology
Seth GSMC and KEM Hospital
Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
8605265390 |
| Fax |
|
| Email |
Sharayup96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Seth GSMC and KEM Hospital
Parel Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth GSMC and KEM Hospital |
| Address |
Department of Anaesthesiology
Seth GSMC and KEM Hospital
Parel Mumbai |
| 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 |
| Dr Shrikanta Oak |
Seth GSMC and KEM Hospital |
Neurosurgery theatre
Department of Neurosurgery,
Seth GSMC and KEM Hospital
Parel Mumbai
Mumbai MAHARASHTRA |
9324134023
shrikanta_oak@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-II Seth GSMC and KEM Hospital |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female in age group of 18 to 65years.
2. Planned for elective surgery under general anaesthesia requiring orotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Patient not willing for study.
2. Abnormal airways or Neck anatomy (Burns or Post
burn contractures).
3. Restrictive neck movement.
4. History of neck tumor and Cervical surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To estimate the optimal depth of insertion of Endotracheal tube using Ultrasound & Clinical parameters
|
After induction and intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the percentage of subjects requiring change in depth of insertion with use of USG |
After completion of study |
| To find the optimal depth of insertion of endotracheal tube in relation to height & neck length in an individual in Indian population |
After completion of study |
|
|
Target Sample Size
|
Total Sample Size="156" Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
Endotracheal intubation is routine procedure in general anaesthesia to maintain the oxygenation and ventilation. Appropriate depth of insertion of endotracheal intubation confirms the safety of patient from endobronchial intubation leading to single lung ventilation, atelectasis and too shallow placed endobronchial cuff will result in vocal cord injury. Among the various techniques such as X-Rays, fiber optic bronchoscopy, ultrasound etc. used to determine the correct depth of endotracheal tube insertion Ultrasound is noninvasive, safe and fairly accurate method. Saline inflated cuff is visualized using ultrasound to confirm the correct endotracheal tube placement and depth of insertion. As length of trachea and distance from teeth to vocal cords varies in individuals a fixed depth or fixed mark on ETT may be inadequate and will vary with height and neck length. As suggested in some studies the proximal part of cuff should be 1.5 cm to 2.5 cm from vocal cords and at Tracheal ring T2 to T4 the ultrasound will be easy guide to determine the endotracheal tube cuff position. Ultrasound can be used to determine the correct depth of ET cuff in Indian adult population and its relation to height, neck length. Anthropometry of Individuals i.e. (Height and Neck Length) affect the optimal depth of insertion of Endotracheal tube. The primary objective of this study is to determine the depth of insertion of Endotracheal tube using Ultrasound and Clinical parameters. Secondary is to find the correlation between the depth of insertion of ETT with height and neck length in Indian population. |