| CTRI Number |
CTRI/2022/06/042979 [Registered on: 02/06/2022] Trial Registered Prospectively |
| Last Modified On: |
30/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Reliability of USG machine in confirming signs of ventilation during anaesthesia in children |
|
Scientific Title of Study
|
Reliability of ultrasonogram in confirmation of endotracheal tube placement compared to chest auscultation when performed by anaesthesia residents-a prospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yokesh J |
| Designation |
Postgraduate |
| Affiliation |
Madras medical college |
| Address |
GH post office, Poonamallee High Road, 3, near park town, Rajiv Gandhi government general hospital, Institute of anaesthesiology and critical care
Chennai
TAMIL NADU
600003
India |
| Phone |
9042844248 |
| Fax |
|
| Email |
yokeshj94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr dhanasekar |
| Designation |
Professor |
| Affiliation |
Madras medical college |
| Address |
Institute of child health and hospital for children. Rina mandal road, Elmore, Chennai.
Chennai
TAMIL NADU
600008
India |
| Phone |
9841032748 |
| Fax |
|
| Email |
dhasaraven@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yokesh J |
| Designation |
Postgraduate |
| Affiliation |
Madras medical college |
| Address |
GH post office, Poonamallee High Road, 3, near park town, Rajiv Gandhi government general hospital, Institute of anaesthesiology and critical care
Chennai
TAMIL NADU
600003
India |
| Phone |
9042844248 |
| Fax |
|
| Email |
yokeshj94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras medical college, Poonamallee high road, Park Town, Chennai 600 003.
|
|
|
Primary Sponsor
|
| Name |
Yokesh J |
| Address |
GH post office, Poonamallee High Road, 3, near park town, Rajiv Gandhi government general hospital, Institute of anaesthesiology and critical care |
| 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 |
| Yokesh |
Institute of child health and hospital for children |
Department of paediatric anaesthesia,Banumati, Rina Mandal road, Egmore, Chennai 600 008
Chennai
TAMIL NADU |
9042844248
yokeshj94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Madras medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Auscultation by stethoscope |
Detecting endotracheal intubation by auscultation of breath sounds |
| Intervention |
Ultrasonogram |
Detection of endotracheal intubation using ultrasonogram |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA PS 1,2
2. Paediatric elective surgeries
3. General anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1. Children with anticipated difficult airway
2. Risk factors for gastric aspiration
3. Known lung disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confirming reliability of USG in determining endotracheal tube position. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of oesophageal and bronchial intubation |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
06/06/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Purpose of research: During intubation endobronchial intubation is the most common malposition encountered. Auscultation shows a sensitivity of only 60% in determining bronchial vs tracheal intubation. Therefore ultrasound which is relatively a new technique for ETT confirmation serves as a real time diagnostic tool with rapid and accurate results.
Design: prospective non randomised controlled trial
Participants: age 3 to 6 years satisfying inclusion criteria
Intervention: intubation done by Anesthesia resident. Primary anaesthesiologist evaluates breath sounds bilaterally by chest auscultation Second anaesthesiologist evaluates lung sliding sign using USG
Main outcome measures: primary outcome will be superiority of USG over chest auscultation in confirming endotracheal tube placement. The secondary outcome will be the incidence of oesophageal vs bronchial intubation. |