| CTRI Number |
CTRI/2024/06/069113 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Estimating the size of tracheal tube used for intubation in children using different regular methods undergoing surgical operations |
|
Scientific Title of Study
|
Prediction of endotracheal tube size using various conventional methods in paediatric surgical population. A comparative 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 Rekha Bai |
| Designation |
Junior Resident 1 |
| Affiliation |
Vijayanagara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari. same as Address1 Bellary KARNATAKA 583104 India |
| Phone |
8431001646 |
| Fax |
|
| Email |
rekharajputh13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rekha Bai |
| Designation |
Junior Resident 1 |
| Affiliation |
Vijayanagara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari. Same as Address 1 Bellary KARNATAKA 583104 India |
| Phone |
8431001646 |
| Fax |
|
| Email |
rekharajputh13@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kiran Chand N |
| Designation |
Associate Professor |
| Affiliation |
Vijayanagara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology Vijayanagara Institute of Medical Sciences, Ballari Same as Address 1 Bellary KARNATAKA 583104 India |
| Phone |
9845857056 |
| Fax |
|
| Email |
nkiranchand@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Vijayanagar institute of Medical sciences
Ballari |
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences |
| Address |
Cantonment, Ballari, Karnataka, India 583104 |
| 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 Rekha Bai |
Vijayanagar Institute of Medical Sciences |
Department of Anaesthesiology Major OT Complex,Cantonment, Ballari, Karnataka, India. Bellary KARNATAKA |
8431001646
rekharajputh13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee , Vijayanagar institute of Medical sciences Bellary |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endotracheal tube Size |
different sized endotracheal tubes based on different formulas will be selected and which one will be correct fit will be selected |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Day(s) |
| Gender |
Both |
| Details |
All paediatric surgical population requiring general anesthesia
ASA I and II
Consenting parents |
|
| ExclusionCriteria |
| Details |
Children with active respiratory infection
Children with laryngeal and tracheal pathologies
Congenital developmental disorders
Malformation associated with head and neck and face
Upper airway obstruction and previous surgeries on the airway |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Selecting best fit endotracheal tube based on Age Height and weight |
Preintubation and at intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the most reliable formula for predicting ETT size in Indian pediatric surgical population |
To identify the most reliable formula for predicting ETT size in Indian pediatric surgical population |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
01/07/2024 |
| 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="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
|
The study will be conducted at the Department of Anaesthesiology and Critical Care, VIMS Ballari. The patients will be selected for the study depending on the inclusion and exclusion criteria. The complete data will be collected from the patients in a specially designed Case Record Form (CRF) which includes history of illness and detailed clinical examination and relevant investigations. Before subjecting the patients for investigations and andanaesthesia, written/informed consent will be obtained from each patient and /or parents or legal guardian. All children will be appropriately premedicated the previous night and the day of surgery. Children will be kept Nil by mouth 6 hours for solids and 2 hours for clear water. After having done preoperative anesthesia drill and taking the child in to the operating theatre (OT) all basic monitors (ECG, SPO2,NIBP, ETCO2,TEMP ) will be attached and the OT temperature will be maintained between 24-26 degree Celsius. General anaesthesia will be induced with inhalational or intravenous induction agent and maintained with inhalational agent in oxygen nitrous oxide mixture. Following complete muscle relaxation after administration of appropriate muscle relaxant, the first attempt of endotracheal intubation was done with uncuffed tube size calculated based on Height {( ID(mm = (Height in Cm /30) + 2)}. Following intubation correct placement will be confirmed by end tidal carbon dioxide ( ETCO2) trace and five point auscultation. Once the tube is secured ,the leak pressure will be measured by closing the pressure relief valve and auscultating over the larynx. The absence of considerable leak at an airway pressure between 10 -25 cms of water is considered as appropriate size. If there is leak at airway pressure lower than 10 cmsH2O , then the size is considered as too small and will be replaced with a tube Size 0.5 mm more than that used . Similarly if there is no leak at all, at airway pressure of 25cms of H2O or more, tube is considered as too large and will be replaced with 0.5mm smaller size. After having secured appropriate tube ventilation will be continued according to the requirements as per normal settings. The final (actual) tube size used will be correlated with the size predicted by ABF, HBF and WBF as follows : - The ABF used will be as follows : Age in years /4 +4 (ID ) - The HBF used will be as follows ( Used primary selection) : Height in Cms/ 30 +2 (ID) - The WBF used will be : weight in Kg/10 +3.5 (ID) Following extubation the children will be monitored in PACU for sorethroat, harseness of voice, cough, aspiration stridor or any other complications. Design of study 1. Observational - Prospective, single group
The statistical package for social sciences ( SPSS ) version 26.0 will be used for statistical analysis. The quantitative variables will be expressed as mean with 95% confidence intervals (95% CI) and will be compared using paired ‘t’ test. Data will be presented as mean ± SD ,number(%) as appropriate. Pearson correlation coefficient test for association of various parameters for selection of ETT and inter rater kappa static for strength of agreement. A p-value less than 0.05 was considered significant. |