| CTRI Number |
CTRI/2024/10/075953 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Comparing Methods for Safer Intubation in Obese Patients: Ultrasound vs. Capnography and chest auscultation " |
|
Scientific Title of Study
|
Comparative study of Ultrasound guided endotracheal intubation as a tool for efficient intubation with chest auscultation and capnography in obese patients.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siya Sachin |
| Designation |
Post Graduate student |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
D-Block, 1st Floor,
Department Of Anaesthesiology, Chettinad Hospital And Research
Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Chennai
N/A
Chennai
TAMIL NADU
603103
India |
| Phone |
8825834285 |
| Fax |
|
| Email |
siyasachin99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR B BALAMURUGAN |
| Designation |
Professor |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
D-Block, 1st Floor,
Department Of Anaesthesiology, Chettinad Hospital And Research
Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Chennai
Chennai
TAMIL NADU
603103
India |
| Phone |
9841544566 |
| Fax |
|
| Email |
drbala.srmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siya Sachin |
| Designation |
Post graduate |
| Affiliation |
Chettinad Academy of Research and Education |
| Address |
D-Block, 1st Floor,
Department Of Anaesthesiology, Chettinad Hospital And Research
Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Chennai
TAMIL NADU
Chennai
TAMIL NADU
603103
India |
| Phone |
8825834285 |
| Fax |
|
| Email |
siyasachin99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute, Chettinad health city, Rajiv Gandhi Salai, Kelambakkam, Chennai, Tamil Nadu, India- 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research Institute |
| Address |
Chettinad Hospital And Research Institute, Chettinad Health City,
Rajiv Gandhi Salai, Kelambakkam, Chennai, Tamil Nadu,
India-603103 |
| 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 |
| Siya Sachin |
Chettinad Academy of Research and Education |
Chettinad Health City
Rajiv Gandhi Salai
Kelambakkam
Chennai
TAMIL NADU |
8825834285
siyasachin99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee for Student Research (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients aged 18-65 years
BMI greater than 30.0 kg/m2
Mallampati class 1-4 |
|
| ExclusionCriteria |
| Details |
Patients refusing to participate in the study
Negative upper lip bite test
Restricted neck movements
Previous history of difficult intubation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if ultrasound is the fastest method of confirmation of correct placement of ETT in comparison to clinical methods of chest auscultation and capnography. |
As soon as patient is received in the operation theatre
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine early identification of the tube being misdirected towards the oesophagus.
Evaluation of ultrasound as a tool for assessment of depth of ET insertion via sliding pleura sign & diaphragmatic excursion.
|
As soon as patient is received in the operation theatre- Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/11/2024 |
| 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="0"
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
|
Endotracheal intubation is an essential skill performed by multiple medical specialists to secure a patient’s airway as well as provide oxygenation and ventilation. The aim of the study is to evaluate ultrasound guided endotracheal intubation in real time, would be the fastest method to confirm correct ETT placement compared to conventional methods of chest auscultation and capnography. The study is a prospective, observational study amongst 40 participants scheduled for elective surgery requiring general anesthesia with endo-tracheal intubation with BMI >30.0 kg/m^2 The primary objective is to determine if ultrasound is the fastest method of confirmation of correct placement of ETT in comparison to clinical methods such as chest auscultation and capnography. The secondary objectives are to determine early identification of the tube being misdirected towards the oesophagus and evaluation of ultrasound as a tool for assessment of depth of ET insertion via sliding pleura sign and diaphragmatic excursion.
|