| CTRI Number |
CTRI/2024/03/063663 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of upper airway ultrasound with Capnography for confirmation of endotracheal tube placement in pediatric patients requiring general anaesthesia |
|
Scientific Title of Study
|
Comparison of Upper Airway Ultrasonography with
Capnography for the Confirmation of Endotreacheal Tube
Placement in Pediatric Patients Undergoing Elective 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 |
Umit |
| Designation |
Post graduate student |
| Affiliation |
ABVIMS and DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
Room no.301 3rd floor Department Of Anaesthesia
ABVIMS AND DR. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
8708762152 |
| Fax |
|
| Email |
umitdhankhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nidhi Yadav |
| Designation |
Associate Professor |
| Affiliation |
ABVIMS and DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
Room no. 301 3rd floor Department Of Anaesthesia
ABVIMS AND DR. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
8826619639 |
| Fax |
|
| Email |
yadavnids@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Umit |
| Designation |
Post graduation student |
| Affiliation |
ABVIMS and DR RAM MANOHAR LOHIA HOSPITAL, NEW DELHI |
| Address |
Room no. 301 3rd floor Department Of Anaesthesia
ABVIMS AND DR. RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
8708762152 |
| Fax |
|
| Email |
umitdhankhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr. Ram
Manohar Lohia
Hospital, Baba Kharak
Singh Marg, Near
Gurudwara Bangla
Sahib, Connaught
Place, New Delhi, Delhi
110001
Central
DELHI |
|
|
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 Umit |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
3rd floor Department Of Anaesthesia
ABVIMS AND DR. RML HOSPITAL
Central
DELHI |
8708762152
umitdhankhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and 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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients for elective surgery under general anesthesia
2.ASA Class I & II |
|
| ExclusionCriteria |
| Details |
1. Presence of any neck mass / neck contractures.
2. Patients who have undergone previous airway surgery or have a history of airway
injury.
3. Patients with known difficult airway. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of the time taken for confirmation of endotracheal tube placement using upper
airway ultrasonography with capnography in paediatric patients undergoing elective surgery under general anaesthesia |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of number of correct identification of tracheal & esophageal intubation using upper airway ultrasonography with capnography in paediatric patients undergoing elective
surgery under general anaesthesia |
Just after placement of endotracheal tube |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
16/03/2024 |
| 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="3"
Days="20" |
|
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 cross sectional observational study to compare upper airway ultrasound with capnography for confirmation of endotracheal tube placement in pediatric patients undergoing elective surgery under general anaesthesia. This study has sample size of 78 paediatric patients. There are few studies comparing capnography and ultrasonography for endotreacheal tube placement confirmation. |