| CTRI Number |
CTRI/2024/07/070585 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Accuracy of ultrasonography to predict endotracheal tube size in neonates |
|
Scientific Title of Study
|
Clinical accuracy of ultrasonography to predict the size of endotracheal tube in neonates: an observational study |
| 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 Ananya Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
9205906870 |
| Fax |
|
| Email |
ananya181998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Goyal Varshney |
| Designation |
Associate Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
9999353519 |
| Fax |
|
| Email |
doc_1998@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Goyal Varshney |
| Designation |
Associate Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI
110001
India |
| Phone |
9999353519 |
| Fax |
|
| Email |
doc_1998@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, Connaught Place, New Delhi, Delhi 110001, India |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001 |
| 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 Ananya Singh |
Lady Hardinge Medical College and Associated Hospitals |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, DIZ Area, Connaught Place, New Delhi, Delhi 110001
Central
DELHI |
9205906870
ananya181998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee For Human Research, Lady Hardinge Medical College & Associated Hospitals |
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 |
Ultrasonography |
Airway measurement will be done using ultrasonography, followed by placing the corresponding size endotracheal tube and it will be observed that the size of endotracheal tube is correct or not. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates undergoing general anaesthesia requiring endotracheal intubation |
|
| ExclusionCriteria |
| Details |
1. Anatomical deformity of upper airway
2. Presence of mass, scar or ulcer in the neck
3. Hemodynamically unstable patient requiring urgent intubation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients in which ultrasonography is clinically accurate to determine the best fit (air leak test) endotracheal tube |
After performing the air leak test after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
24/07/2024 |
| 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="2"
Days="15" |
|
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
|
Endotracheal tube (ETT) is the definitive method for the management of airway during general anaesthesia in neonates undergoing surgery. Conventionally, ETT size in neonates is selected according to the gestational age and weight. However, these criteria are not always accurate to estimate the correct ETT size and multiple trials of intubation and tube changes may be required to place an appropriate size ETT. This may cause hypoxia and may also lead to airway mucosal edema. An inappropriately sized ETT can lead to morbidity as large ETT can cause airway damage and injury, subglottic edema, post extubation stridor, local ischemia, scar formation and subglottic stenosis after a prolonged duration of intubation. A smaller sized ETT will lead to higher leaks and thus, insufficient ventilation, high airway resistance, poor monitoring of end-tidal gases and higher risk of aspiration and thus, lung infections. Therefore, it is essential to determine the appropriate size of ETT for each patient at the first attempt. Ultrasonography (USG) is a safe and reliable modality which allows for a real time and non-invasive assessment of the airway and subglottic area for estimation of ETT size, thereby reducing the associated complications associated with an incorrect size ETT. This study therefore, aims to determine the accuracy of USG to predict the size of endotracheal tubes in neonates. Multiple studies have been done for estimating the appropriate size of ETT in paediatric population using ultrasonography. However, there is limited published literature related to determining the ETT size by ultrasonography in neonates. |