| CTRI Number |
CTRI/2024/03/063611 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparing tracheal tube optimal placement using ultrasound and auscultation in paediatric age group |
|
Scientific Title of Study
|
COMPARISON OF ULTRASOUND GUIDED LUNG SLIDING SIGN WITH CHEST AUSCULTATION FOR CONFIRMATION OF OPTIMUM DEPTH OF ENDOTRACHEAL TUBE PLACEMENT IN PAEDIATRIC PATIENTS UNDERGOING SURGERY
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 Neerja Banerjee |
| Designation |
Professor and Head of Department |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) and Dr RML hospital |
| Address |
Department of anaesthesia,Room no 304 third floor PGI building, Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) AND DR RML Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neerja Banerjee |
| Designation |
Professor and Head of Department |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) AND DR RML Hospital |
| Address |
Department of anaesthesia,Room no 304 third floor PGI building , Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) AND DR RML Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neerja Banerjee |
| Designation |
Professor and Head of Department |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) AND DR RML Hospital |
| Address |
Department of anaesthesia,Room no 304 third floor PGI building Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) AND DR RML Hospital New Delhi
Central
DELHI
110001
India |
| Phone |
9810517575 |
| Fax |
|
| Email |
neerja.banerjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) AND DR RML Hospital New Delhi
110001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Nil] |
|
|
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 Adeeba Sameen |
Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) and Dr RML hospital |
Department of anaesthesia,Room no 304,PGI building 3rd floor, Atal Bihari Vajpayee Institute of Medical Sciences (ABVIMS) and Dr RML Hospital, New Delhi 110001
Central
DELHI |
9444474663
adeebasameen08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, ABVIMS, Dr RML Hospital, New Delhi |
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 |
Endotracheal tube placement |
Optimum placement of endotracheal tube either by auscultation or by ultrasound guided lung sliding sign. The duration of the intervention will be around 30 seconds to 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of ASA grade I and II
2.Patients posted for elective surgery under general anaesthesia requiring endotracheal tube.
3.Patients of age between 1 and 12 years |
|
| ExclusionCriteria |
| Details |
1.Anticipated difficult airway like retrognathia, maxillomandibular abnormalities and other
congenital deformities.
2.Airway anomalies
3.Vascular malformation of neck
• Congenital cardiac anomalies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare ultrasound guided lung sliding sign with chest auscultation for confirmation of
optimum depth of endotracheal tube placement in paediatric patients undergoing elective surgery
under general anaesthesia |
At baseline, that is, at the time of intervention only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the effects of age, height, & weight on the optimum depth of endotracheal tube placement in paediatric population. |
At baseline, that is, at the time of intervention only |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/03/2024 |
| 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="5"
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
|
This is a randomized prospective study to compare ultrasound guided lung sliding sign with chest auscultation for confirmation of
optimum depth of endotracheal tube placement in paediatric patients undergoing elective surgery under general anaesthesia.The procedure and the associated side effects will be explained to the patients’ guardians in his/her own bilingual language. An endotracheal tube will be inserted either by auscultation or by lung sliding sign. Neck ultrasonography will be performed to confirm the optimal placement. All ASA recommended monitoring would be done for this procedure. |