| CTRI Number |
CTRI/2024/10/075555 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
How Different Head Positions Affect Intubation Depth in Children. |
|
Scientific Title of Study
|
EVALUATION OF INFLUENCE OF HEAD POSITION VARIATIONS ON THE DEPTH OF ENDOTRACHEAL INTUBATION 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 Ragini |
| Designation |
Post Graduate student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia, Main OT building,Vardhman Mahavir Medical college and Safdarjung Hospital ,New Delhi -29
South
DELHI
110029
India |
| Phone |
8860660993 |
| Fax |
|
| Email |
Raginisharmadps2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Rani Sharma |
| Designation |
Director Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi -29
Department of Anaesthesia, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi -29
South
DELHI
110029
India |
| Phone |
9968604376 |
| Fax |
|
| Email |
drkavitadn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ragini |
| Designation |
Post Graduate Student |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia,Main OT building, Vardhman Mahavir Medical college and Safdarjung Hospital ,New Delhi-29
South
DELHI
110029
India |
| Phone |
8860660993 |
| Fax |
|
| Email |
Raginisharmasps2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Main OT building, VMMC & Safdarjung Hospital, Ansari Nagar, New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia,Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital ,New Delhi -29 |
| 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 Ragini |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital,New Delhi -29
South
DELHI |
8860660993
Raginisharmadps2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VMMC and Safdarjung Hospital Institutional committee |
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 |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The study will include children with ASA I and II status, between the age group of 4 to 12 years, planned for elective surgery under general anaesthesia with endotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Patients will be excluded if they presented with: - 1) Patients with limited head and neck movement. 2) Patients with difficult airway and any known or suspected airway anomalies. 3) Patients requiring preformed/ reinforced/ nasal endotracheal tubes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the distance between the endotracheal tip and the carina using fibreoptic bronchoscope with flexion and extension of head relative to neutral head position in paediatric patients. |
5 minutes after intubating the patient. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Correlation of the changes in the depth of endotracheal intubation caused by head position changes with the height of the patient 2) Correlation of the changes in the depth of endotracheal intubation caused by head position changes with the age of the patient . |
10 mins after induction |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/10/2024 |
| 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="0"
Months="6"
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
|
My study is aimed to evaluate the influence of head position variations on the depth of endotracheal intubation in paediatric patients. The child will be undergoing a routine detailed pre-anaesthetic check-up. Informed consent and assent will be taken by parents/ guardians . Child will be administered general anaesthesia as per the standard protocol. Endotracheal tube of appropriate size will be inserted to secure the airway and will be fixed according to the precalculated values. A fibreoptic bronchoscope will be introduced to confirm the position of the endotracheal tube when head is 45 degrees flexed, 45 degrees extended and will be repositioned if necessary. Distances between the ETT tip to the carina and vocal cords to the carina will be measured using FOB in neutral, 45°head flexion, 45°head extension . Anaesthesia will be maintained and reversed on discretion of attending anaesthesiologist |