| CTRI Number |
CTRI/2024/11/077174 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Scanning the neck to measure the size of the airway tube in children undergoing general anaesthesia for surgery |
|
Scientific Title of Study
|
An Observational study of endotracheal tube size estimation with ultrasound guided subglottic diameter measurement in paediatric patients undergoing 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 |
Dr R Pavithra |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology
Sree Balaji Medical College and Hospital CLC works road Chrompet Chennai
Chennai TAMIL NADU 600044 India |
| Phone |
9003867560 |
| Fax |
|
| Email |
pavithravi76@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yogaraj |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology Sree Balaji Medical College and Hospital CLC Works road Chrompet Chennai
Chennai TAMIL NADU 600044 India |
| Phone |
9884678869 |
| Fax |
|
| Email |
yogaraj1986@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Yogaraj |
| Designation |
Professor of Anaesthesiology |
| Affiliation |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology Sree Balaji Medical College and Hospital CLC Works road Chrompet Chennai
Chennai TAMIL NADU 600044 India |
| Phone |
9884678869 |
| Fax |
|
| Email |
yogaraj1986@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sree Balaji Medical College, No 7, CLC Works road, Chrompet, Chennai-600044 |
|
|
Primary Sponsor
|
| Name |
Sree Balaji Medical College and Hospital |
| Address |
Department of Anaesthesiology Sree Balaji Medical College and Hospital Department of Anaesthesiology No 7 CLC Works road Chrompet Chennai 44 |
| Type of Sponsor |
Private 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 Pavithra |
Sree Balaji Medical College |
Sree Balaji Medical College and Hospital
Department of Anaesthesiology No 7 CLC Works road Chrompet Chennai 44 Chennai TAMIL NADU |
9003867560
pavithravi76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE BALAJI MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
ASA I and II
Patient undergoing elective surgery with ET intubation under GA |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful first pass intubation using endotracheal tube size (OD) matched with USG measurement of subglottic diameter |
successful or failed first pass intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to decide the ET tube size from the time of scanning to matching the ODs |
in seconds |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
02/12/2024 |
| 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="2" Months="0" 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
|
After doing routine pre-anaesthetic
evaluation ,Paediatric
patients undergoing surgery under general anaesthesia with ET Tube intubation
will be enrolled. Patient will be kept NPO for solids 8hrs,
liquids 2hrs
prior to surgery. General
anaesthesia will be initiated by the attending anaesthesiologist. After
loss of consciousness, bag and mask
ventilation will be confirmed and weight based dose of long acting muscle
relaxant will be given. The patient will be ventilated for 4minutes while
performing the sonography.GE LOGIQ P7 machine with high resolution linear probe (4.5-13
MHz) in B mode will be used for scanning.
With head in extension and neck flexed (sniffing position) initial
scanning will be done in sagittal section in the midline immediately above
supra-sternal notch upwards. This is to identify the tracheal rings, and
cricoid cartilage. At the level of cricoid cartilage, the probe will be rotated
transversely with marker pointing towards right side. The vocal cords are identified in transverse
section by moving the probe upwards. The
probe is then moved again downwards to identify the sub glottis immediately
below the vocal cords. Transverse air column
diameter will be measured at the cephalic half of cricoid cartilage taken as subglottic
diameter. This is the outer
diameter of the ETT that can be used for the patient.
Cuffed
ETT OD = Subglottic
diameter – 1mm
Uncuffed ETT OD =
Subglottic diameter
The ETT will be chosen by matching the measured OD with
manufacturers OD. Time taken to decide the size of the ETT from the time of
scanning till matching the OD will be noted. Successful first pass of the ETT
will be observed. After intubation, cuff pressure will be inflated to 15-20 cmH2O and audible
air leak with stethoscope will be noted. Leak occurring at <10cmH2O ETT will be exchanged with
0.5mm smaller size ETT, Leak
occurring at >20cm H20 will be exchanged with 0.5mm larger size ETT.
Similarly, circuit
pressure equilibration will be checked. Closed circuit will be connected to the
ETT and flow rate will be set to 6L/min
with a closed adjustable pressure limiting valve closed to 30cmH2O allowing the
circuit to fill up and pressurize to a circuit pressure of 30cm H2O. Then the
flow meter will be closed fully and fall in pressure will be noted for 10
seconds , when the pressure equilibrates to a new value at the end of 10
seconds .If it equilibrates to 10 to 20 cm H2O after 10secs ETT will be
considered appropriate. ETT will be considered large if the circuit pressure
equilibrates at >20 cm H20 and ETT size will be considered small if the circuit
pressure equilibrates to <10 cm H20 after 10 secs and will be changed
accordingly by 0.5mm smaller or larger respectively. Adequate ventilation will
be confirmed. The final size of the ETT will be compared with age based
formula.
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