CTRI Number |
CTRI/2022/12/047979 [Registered on: 08/12/2022] Trial Registered Prospectively |
Last Modified On: |
02/12/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Medical Device Surgical/Anesthesia Other (Specify) [Hospital based case series] |
Study Design |
Other |
Public Title of Study
|
To choose the correct size of windpipe using ultrasound. |
Scientific Title of Study
|
Accuracy of ultrasound to predict endotracheal tube size in paediatric patients: Hospital based case series study†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DR RAMESH KOPPAL |
Designation |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
Affiliation |
S NIJALINGAPPA MEDICAL COLLEGE |
Address |
PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102 PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102 Bagalkot KARNATAKA 587102 India |
Phone |
9845504515 |
Fax |
|
Email |
rameshkoppaldr@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
DR RAMESH KOPPAL |
Designation |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
Affiliation |
S NIJALINGAPPA MEDICAL COLLEGE |
Address |
PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102 PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGY,
S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102 Bagalkot KARNATAKA 587102 India |
Phone |
9845504515 |
Fax |
|
Email |
rameshkoppaldr@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR ANUSHA N |
Designation |
PG IN ANAESTHESIOLOGY |
Affiliation |
S NIJALINGAPPA MEDICAL COLLEGE |
Address |
DEPARTMENT OF ANAESTHESIOLOGY,
S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102 DEPARTMENT OF ANAESTHESIOLOGY,
S NIJALINGAPPA MEDICAL COLLEGE, BAGALKOT-587102 Bagalkot KARNATAKA 587102 India |
Phone |
7899563950 |
Fax |
|
Email |
anushanarayan89@gmail.com |
|
Source of Monetary or Material Support
|
S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL BAGALKOT |
|
Primary Sponsor
|
Name |
Dept of Anaesthesia |
Address |
S N Medical college
Bagalkot |
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 RAMESH KOPPAL |
S Nijalingappa medical college and HSK hospital |
Paediatric OT complex, 1st floor. Bagalkot KARNATAKA |
9845504515
rameshkoppaldr@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
S NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE |
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 |
ENDOTRACHEAL TUBE INTUBATION |
subglottic measurement by ultrasound followed by intubation with appropriate size endotracheal tube.
Duration: 18months |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
6.00 Year(s) |
Gender |
Both |
Details |
1.Age group 2-6years.
2.ASA I-III
3.Elective surgeries under GA
|
|
ExclusionCriteria |
Details |
1.Patient with any anticipated difficult airway.
2.Patient with any anatomical deformity of upper airway
3.Patient with previous surgery involving upper airway.
4.Patient with any obvious scars, mass, or ulcer which will interfere with ultrasound examination of neck.
5.Patient‘s attenders refusal to give consent.
6.Patient with history of previous prolonged intubation
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
ultrasound guided estimated ETT size is accurate compared to conventional height and weight formula based calculated ETT size. |
24 Hours |
|
Secondary Outcome
|
Outcome |
TimePoints |
ultrasound measured ETT size prevents the need of re attempts of intubation which may be harmful to the paediatric patients. |
24 hours |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/12/2022 |
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 Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NONE YET |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Selection of an optimal endotracheal tube size is crucial in pediatric patients and are mainly done with the age , height based formula routinely which fails to yield an accurate size ETT resulting in increase in need of reattempts in intubation causing acute and chronic airway injury . Ultrasound being one of the advanced, reliable and feasible modality which helps in measuring appropriate ETT size. The aim of the study is to determine the accuracy of ultrasound to estimated the real-time ETT size and to prevent the need of reintubation as it is dangerous to pediatric airway. Objectives of this study is : To identify the accuracy of ultrasound in assessing the correct endotracheal tube size and to assess the number of attempts required to change the ultrasound estimated estimated endotracheal tube size based on air leak test. This is a hospital base case series study. Thirty ASA I-III patients of age 2-6 years under going elective surgery requiring general anaesthesia are choosen. After obtaining institutional ethical clearance, written informed consent will be taken from patient’ s parents and guardians. After induction with general anaesthesia a real-time USG guided subglottic diameter will be measured. Initial ETT will be choosen according to measurement made using USG guidance and leak test is performed to determine the best fit ETT size. The study parameter are the external diameter(OD) of ETT and the internal diameter of subglottic area measured by USG guidance. |