| CTRI Number |
CTRI/2024/06/068762 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare three methods i.e transtracheal ultrasonography, end tidal capnography and unilateral chest auscultation to confirm endotracheal tube position in children during intubation. |
|
Scientific Title of Study
|
Comparison of transtracheal ultrasonography, end tidal capnography, and chest auscultation for confirmation of endotracheal tube placement in paediatric 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 |
Dr Raj Singh |
| Designation |
PG Resident |
| Affiliation |
Vardhaman mahavir medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and critical care, vardhaman mahavir medical College and safdurjung hospital,Ansari nagar, New Delhi
South West
DELHI
110029
India
New Delhi
DELHI
110029
India |
| Phone |
7000682422 |
| Fax |
|
| Email |
rajsingh24747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Bamba |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhaman mahavir medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and critical care, vardhaman mahavir medical College and safdurjung hospital,Ansari nagar, New Delhi
South West
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 |
Vardhaman mahavir medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and critical care, vardhaman mahavir medical College and safdurjung hospital,Ansari nagar, New Delhi
South West
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 critical care, vardhaman mahavir medical College and safdurjung hospital, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| Address |
Department of Anaesthesia and critical care, vardhaman mahavir medical College and safdurjung hospital,Ansari nagar, New Delhi
South West
DELHI
110029
India |
| 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 Raj Singh |
VMMC and Safdarjung Hospital |
Department of Anaesthesia and critical care, vardhaman mahavir medical College and safdurjung hospital,Ansari nagar, New Delhi
South West
DELHI
110029
India
New Delhi
DELHI |
07000682422
rajsingh24747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical college and Safdarjung Hospital, Institutional Ethics Committee IPRC |
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 |
Comparison of transtracheal ultrasonography, end tidal capnography and chest auscultation for
confirmation of endotracheal tube placement in paediatric patients. |
An experienced anaesthesiologist will introduce the laryngoscope through the incisors, a timer will be started(start time common for all). Patient will undergo endotracheal intubation with appropriate sized cuffed endotracheal tube. After intubation, endotracheal tube cuff will be inflated, connected to circuit and mechanical ventilation will be initiated. Three observers will be ready for assessment of endotracheal tube placement confirmation with their respective methods, that is transtracheal ultrasonography, capnography and unilateral chest auscultation. First observer will use ultrasonography to visualise the trachea and record the time taken for the endotracheal tubes transit through it while the anaesthesiologist completes the intubation. Meanwhile, a second observer will validate that the ETT had been placed in the trachea by observation of square waveform capnography. The third observer will confirm endotracheal tube placement by auscultating the chest for unilateral (right sided) air entry. Time will be noted from introduction of laryngoscope blade tip through incisors(start time) till confirmation of endotracheal tube placement by their respective technique(three separate and independent stop times).
In case of accidental oesophageal intubation detected by any of three methods, we will proceed for reintubation and note which method detected oesophageal intubation first. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients between 2-10 years who meet the standards of the American Society of
Anesthesiologists (ASA) grade I, II, undergoing surgery under general anaesthesia requiring
endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway.
2. Congenital anomalies of head, face and neck, cardiovascular and respiratory system |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The mean time taken to confirm endotracheal tube placement using transtracheal
ultrasonography, end-tidal capnography and chest auscultation in paediatric patients. |
At Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the sensitivity & specificity of transtracheal ultrasonography & chest
auscultation for confirmation of endotracheal tube placement in paediatric patients taking end tidal capnography as gold standard. |
At base line |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/06/2024 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [charu.bamba@gmail.com].
- For how long will this data be available start date provided 30-09-2025 and end date provided 22-09-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
The proper location of the ETT can be determined using a variety of techniques, such as intubation under direct view, observation of the movements of the chest wall, auscultation of unilateral breath sound, end-tidal carbon dioxide (EtCO2) monitoring, fiberoptic bronchoscopy, and a chest X-ray. However, among all of them, capnography is regarded as the gold standard. The current study is conducted with the primary objective to compare mean time taken to confirm endotracheal tube placement using transtracheal ultrasonography with end-tidal capnography and chest auscultation in paediatric patients. The methodology will be once an experienced anaesthesiologist introduces the laryngoscope through the incisors, a timer will be started(start time common for all). Intubation will be done, endotracheal tube cuff will be inflated, connected to circuit and mechanical ventilation will be initiated. Three observers will be ready for assessment of endotracheal tube placement confirmation with their respective methods, that is transtracheal ultrasonography, capnography and unilateral chest auscultation. |