| CTRI Number |
CTRI/2024/02/062295 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To measure breathing tube size with Ultrasound and compare to age related formula in children who undergo surgeries under general anesthesia. |
|
Scientific Title of Study
|
The accuracy of ultrasound to predict endotracheal tube diameter in pediatric population undergoing general anaesthesia when compared to traditional age based formulae. A Prospective Randomized Comparative 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 |
Anish Waghray |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences , Bibinagar. |
| Address |
Dept. Of Anaesthesiology , All India Institute of Medical Sciences Bibinagar .
Hyderabad .
Telangana
India
Hyderabad TELANGANA 508126 India |
| Phone |
9966883424 |
| Fax |
|
| Email |
anishwaghray@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences , Bibinagar. |
| Address |
Dept. Of Anaesthesiology , All India Institute of Medical Sciences Bibinagar .
Hyderabad .
Telangana
India
Hyderabad TELANGANA 508126 India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ayya Syama Sundar |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences , Bibinagar. |
| Address |
Dept. Of Anaesthesiology , All India Institute of Medical Sciences Bibinagar .
Hyderabad .
Telangana
India
TELANGANA 508126 India |
| Phone |
8179309677 |
| Fax |
|
| Email |
sasyasyama@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences , Bibinagar. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences , Bibinagar. |
| Address |
All India Institute of Medical Sciences , Bibinagar. Hyderabad 508126 . Telangana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anish Waghray |
All India Institute of Medical Sciences , Bibinagar. |
Department of Anaesthesiology , Room no 49 , A Block ,Ground Floor .All India Institute of Medical Sciences , Bibinagar. 508126 Hyderabad TELANGANA |
9966883424
anishwaghray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC BBN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q381||Ankyloglossia, (2) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (3) ICD-10 Condition: Z412||Encounter for routine and ritual male circumcision, (4) ICD-10 Condition: N602||Fibroadenosis of breast, (5) ICD-10 Condition: N433||Hydrocele, unspecified, (6) ICD-10 Condition: Q181||Preauricular sinus and cyst, (7) ICD-10 Condition: Q531||Undescended testicle, unilateral, (8) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
age related formula |
age related formula for endo tracheal tube size is used in one group of pediatric patients undergoing general anaesthesia.These calculations will be done at baseline. |
| Intervention |
ultrasound to predict endotracheal diameter |
using ultrasound to measure sub glottic diameter to predict endo tracheal tube size in pediatric patients undergoing general anesthesia. These calculations will be done at baseline . |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 6 months to 12 years.
2.Elective surgery requiring General Anaesthesia
3.ASA 1 and 2
|
|
| ExclusionCriteria |
| Details |
1.Patients with development anomalies of face/skull
2.Patients with surgeries for tracheal / laryngeal pathology
3.Emergency surgery
4.Recent Upper Respiratory Tract Infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Intubation by
1 Age related formula
2 usg measurement
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 number of endotraceal tubes used / wasted |
post laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
29/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="10" Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A formula to predict the correct size of the endotracheal tube (ETT) to
be used in the paediatric patient was first proposed by Cole in 1957 and this
is the most commonly used formula even today. Due to the wide variations in the
size of children and the frequent inaccuracy of the calculated ETT size, other
complex formulae using multiple variables such as age, height and weight were
proposed, but did not gain wide use in clinical practice. Intubation of
paediatric patients with an ETT that is too small may result in insufficient
ventilation, poor reliability of end-tidal gas monitoring, leakage of
anaesthetic gases into the operating room environment, and an enhanced risk of
aspiration. In contrast, an ETT that is too large can cause upper airway damage
(e.g., laryngeal oedema, stridor, local ischaemia, ulceration, granulation,
scar formation) and potential for subsequent subglottic stenosis. Repeated laryngoscopies and reintubations may be needed to identify
the appropriately sized tube. Some recent reports suggest that the diameter of
the subglottic upper airway can be determined by ultrasound in young adults and
paediatric patients. ETT size
in paediatric population is traditionally determined by age related formulae. Altogether 22 formulae to estimate appropriate endotracheal
tube size for paediatric patients (age 0-12 years) were identified: 12
age-based formulas for tubes without a cuff, 4 height-based formulas for tubes
without a cuff, 2 weight-based formulas for tubes without a cuff and one
multivariate formula for tubes without a cuff as well as 3 age-based formulas
for cuffed endotracheal tubes.
Ultrasound has been used in adults to verify accurate
placement of ETT but minimally used in paediatric population. Ultrasound can
reliably measure the sub glottic diameter which corresponds to maximum outer
diameter of ET tube that can be secured. This will also help in reducing wastage of ET tubes,
eventually helping with reducing the economic burden and being environmentally
friendly. |