| CTRI Number |
CTRI/2025/09/093976 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two ways to check breathing tube placement by putting breathing tube in side-lying position, by camera(video laryngoscope) vs. ultrasound |
|
Scientific Title of Study
|
Evaluation of Endotracheal tube placement using Video laryngoscope versus Point of Care Ultrasound for intubation in lateral position- A Randomized Controlled Trial |
| 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 Ishita Biswas |
| Designation |
Post Graduate Trainee-1 (MD Anaesthesiology) |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology ,Kalinga Institute of Medical Sciences ,Third Floor ,Bhubaneshwar ,Orissa
Khordha ORISSA 751024 India |
| Phone |
7602687472 |
| Fax |
|
| Email |
ishita30dec@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof. (Dr.) Saswati Das |
| Designation |
Professor ,Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology ,Kalinga Institute of Medical Sciences ,Third Floor ,Bhubaneshwar ,Orissa
Khordha ORISSA 751024 India |
| Phone |
9910760328 |
| Fax |
|
| Email |
saswati.das@kims.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Prof. (Dr.) Saswati Das |
| Designation |
Professor ,Department of Anaesthesiology |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Kalinga Institute of Medical Sciences, Third Floor, Bhubaneshwar ,Orissa
Khordha ORISSA 751024 India |
| Phone |
9910760328 |
| Fax |
|
| Email |
saswati.das@kims.ac.in |
|
|
Source of Monetary or Material Support
|
| Kalinga Institute of Medical Sciences(Infrastructure support) |
|
|
Primary Sponsor
|
| Name |
Dr Ishita Biswas |
| Address |
Department of Anaesthesiology, Kalinga Institute of Medical Sciences ,Third Floor ,Bhubaneshwar ,Orissa, PIN 751024 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Ishita Biswas |
Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences |
Department of Anaesthesiology ,Kalinga Institute of Medical Sciences ,Third Floor ,Bhubaneshwar ,Orissa Khordha ORISSA |
7602687472
ishita30dec@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,KALINGA INSTITUTE OF MEDICAL SCIENCE |
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 |
Evaluation of endotracheal tube placement using video laryngoscope versus point of care ultrasound for intubation in lateral position. |
Group A - Intubation by Video laryngoscope |
| Comparator Agent |
Evaluation of endotracheal tube placement using video laryngoscope versus point of care ultrasound for intubation in lateral position. |
Group B- Intubation by Direct laryngoscope |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex aged between 18-80 years.
2.BMI less than 30 kg/m2
3.Posted for elective surgeries under General anesthesia |
|
| ExclusionCriteria |
| Details |
1.Patients with anticipated difficult intubation.
2.Pregnancy
3.Gastroesophageal Reflux Disease
4.Obese patients
5.Emergency surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time taken for insertion of Endotracheal tube in minutes.
|
Immediately after confirmation of tracheal intubation by capnography. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of successful attempts taken for ETT insertion
Number of esophageal intubations
Post operative complications like sore throat, hoarseness of voice & blood staining around the cough.
|
Immediately after confirmation of tracheal intubation by capnography. |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
10/09/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study looks at two different ways to check if a breathing tube is correctly placed in patients who are lying on their side during surgery or emergency care. One method uses a video laryngoscope, which is a small camera that helps doctors see the throat clearly, and the other uses an ultrasound device at the bedside. The goal is to find out which method is more accurate and effective for confirming the correct placement of the breathing tube. |