| CTRI Number |
CTRI/2025/10/096744 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two ultrasound methods to check if a breathing tube is placed correctly in children under general anaesthesia. |
|
Scientific Title of Study
|
Comparison of efficacy of trans-tracheal ultrasonography with lung sliding sign for endotracheal tube placement confirmation in paediatric patients under general anaesthesia. |
| 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 Rajul Rana |
| Designation |
Postgraduate student |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung hospital, Ansari Nagar, South Delhi, 110029, India
New Delhi
DELHI
110029
India |
| Phone |
9818596569 |
| Fax |
|
| Email |
rajulrana92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung hospital, Ansari Nagar, South Delhi, 110029, India
New Delhi
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, VMMC and Safdarjung hospital, Ansari Nagar, South Delhi, 110029, India
New Delhi
DELHI
110029
India |
| Phone |
9811270511 |
| Fax |
|
| Email |
charu.bamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia and intensive care, Ground floor, Main OT Complex, VMMC and Safdarjung hospital , Ansari nagar , 110029, India |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical college and Safdarjung hospital |
| Address |
Vardhman Mahavir Medical college and Safdarjung hospital, Ansari nagar, New Delhi, 110029 |
| 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 Rajul Rana |
Vardhman Mahavir Medical College and Safdarjung hospital |
Department of Anaesthesia and Intensive Care, first floor,OT1 Complex, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi, 110029, India
New Delhi
DELHI |
9818596569
rajulrana92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
capnography |
Via capnography, we will confirm correct endotracheal tube placement |
| Comparator Agent |
lung sliding |
using ultrasound over lung field to confirm correct tracheal intubation |
| Comparator Agent |
Ultrasound confirmation at suprasternal notch |
Using ultrasound to confirm correct tracheal intubation at suprasternal notch |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
All paediatric patients who meet the standards of the American Society of Anaesthesiologists ASA grade 1,2,3 and aged between 2 to 10 years undergoing surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway. Congenital anomalies of head, face and neck, cardiovascular and respiratory system.
Known case of airway obstructive disorders like bronchial asthma, respiratory tract infection and pneumothorax etc. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken by different confirmation methods to confirm correct tracheal intubation placement |
Time starts once the laryngoscope passes the incisors and stops when (1) visualisation of tracheal tube at suprasternal notch in trachea (2) visualisation of positive lung sliding sign (3) capnograph waveform. This is expected to be about 15-45 seconds from the time of intubation as per previous studies |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
11/12/2025 |
| 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="1"
Months="6"
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 randomised comparative study will compare the efficacy of trans-tracheal ultrasonography with lung sliding sign for endotracheal tube placement confirmation in paediatric patients under general anaesthesia. A total of 94 patients will be randomised into two groups. In one group, trans-tracheal ultrasound will be used and in other group, lung sliding sign will be used. Then, time taken by the two techniques will be noted for comparison of efficacy. |