| CTRI Number |
CTRI/2022/09/045860 [Registered on: 26/09/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
FOR CONFIRMATION OF ENDO-TRACHEAL TUBE PLACEMENT WHICH TECHNIQUE IS BETTER IN PEDIATRIC PATIENTS ? UPPER AIRWAY ULTRASONOGRAPHY OR END-TIDAL CAPNOGRAPHY ? |
|
Scientific Title of Study
|
RAPID CONFIRMATION OF ENDO-TRACHEAL TUBE PLACEMENT BY UPPER AIRWAY ULTRASONOGRAPHY AND END-TIDAL CAPNOGRAPHY IN PEDIATRIC PATIENTS REQUIRING INTUBATION FOR ELECTIVE SURGERIES UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SANJAY KUMAR GUPTA |
| Designation |
PG Resident Batch 2020 |
| Affiliation |
Dr. S N Medical College, JODHPUR |
| Address |
Department Of Anesthesia And critical care
Dr. S N Medical College, JODHPUR
Jodhpur
RAJASTHAN
342001
India |
| Phone |
|
| Fax |
|
| Email |
sk2211gupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NEELAM MEENA |
| Designation |
Professor |
| Affiliation |
Dr. S N Medical College, JODHPUR |
| Address |
Department Of Anesthesia And critical care
Dr. S N Medical College, JODHPUR
Jodhpur
RAJASTHAN
342001
India |
| Phone |
|
| Fax |
|
| Email |
drneelamsiddhimeena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NEELAM MEENA |
| Designation |
Professor |
| Affiliation |
Dr. S N Medical College, JODHPUR |
| Address |
Department Of Anesthesia And critical care
Dr. S N Medical College, JODHPUR
Ganganagar
RAJASTHAN
342001
India |
| Phone |
|
| Fax |
|
| Email |
drneelamsiddhimeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. S N Medical College, JODHPUR |
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College JODHPUR |
| Address |
Dr. S N Medical College
Shastri Nagar, Residency Road
JODHPUR
RAJASTHAN
PIN 342001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SANJAY KUMAR GUPTA |
MDM Hospital |
OT Complex
Department Of Anesthesia And Critical care
First Floor
MDM Hospital, JODHPUR
Jodhpur
RAJASTHAN |
9672282211
sk2211gupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Dr. Sampurnanand Medical College, JODHPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
The patients of age 5-14 yrs of either gender of ASA category I and II undergoing general elective surgeries under general anesthesia who are hemodynamically stable and declared fit in preanesthetic check-up. |
|
| ExclusionCriteria |
| Details |
Patient excluded from this study if refused by patient’s parents, patients undergoing emergency surgery, patients with increased risk of aspiration and patients with abnormal or distorted anatomy of the pharynx, limited mouth opening, significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease or having any anatomical abnormality. Patients also excluded from this study who have obstruction of the airway beyond the larynx like foreign body, masses (cancer), strictures, congenital obstruction, vocal cord scarring, inflammatory conditions like laryngitis, bronchitis, laryngeal pappilomatosis etc. Patients also excluded from this study with decreased compliance of lungs like COPD, asthma, silicosis, asbestosis, pneumonitis etc. Patients also excluded from this study who have history of prematurity, seizures, syndromic babies and congenital heart disease and history of recent upper respiratory tract infection. |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the upper airway ultrasonography and End tidal Capnography in confirmation of endotracheal tube placement in term of time (in sec.) taken from intubation to confirmation of endotracheal tube position in pediatric patients requiring intubation for elective surgeries under general anesthesia. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the sensitivity, specificity, positive predictive value and negative predictive value of upper airway ultrasonography and End tidal Capnography in the rapid confirmation of endotracheal tube placement in pediatric patients requiring intubation for elective surgeries under general anesthesia. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/09/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BY COMPARISON OF CONFIRMATION OF
ENDO-TRACHEAL TUBE PLACEMENT BY UPPER AIRWAY ULTRASONOGRAPHY AND END-TIDAL CAPNOGRAPHY
IN PEDIATRIC PATIENTS REQUIRING INTUBATION FOR ELECTIVE SURGERIES UNDER GENERAL
ANAESTHESIA, WE WISH TO SEE WHICH TECHNIQUE IS MORE SENSITIVE AND LESS TIME CONSUMING |