| CTRI Number |
CTRI/2025/02/081222 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Ballotobility technique to know midtracheal position of endotracheal tube-confirming with fibreoptic bronchoscope |
|
Scientific Title of Study
|
Ballotability of cuff to confirm midtracheal position of endotracheal tube correlating with gold standard-fibreoptic bronchoscope-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 |
G S Proktha |
| Designation |
MD Anaesthesia Junior resident |
| Affiliation |
ESIC Medical College and PGIMSR |
| Address |
2ND Floor OT Complex, Department of Anaesthesiology, ESIC MC and PGIMSR Rajajinagar, Bangalore
Bangalore
KARNATAKA
560016
India |
| Phone |
9494029506 |
| Fax |
|
| Email |
gsproktha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Dhummansure |
| Designation |
Head of Department |
| Affiliation |
ESIC Medical College and PGIMSR |
| Address |
2nd Floor OT Complex,Department of Anaesthesiology,ESIC MC and PGIMSR,Rajajinagar,Bangalore
Bangalore
KARNATAKA
560016
India |
| Phone |
9980050864 |
| Fax |
|
| Email |
10drdeepak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
G S Proktha |
| Designation |
MD Anaesthesia Junior Resident |
| Affiliation |
ESIC Medical College and PGIMSR |
| Address |
2nd Floor OT Complex,Department of Anaesthesiology,ESIC MC and PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560016
India |
| Phone |
9494029506 |
| Fax |
|
| Email |
gsproktha@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MC and PGIMSR, Rajajinagar, Bangalore, 560010, India |
|
|
Primary Sponsor
|
| Name |
Dr G S Proktha |
| Address |
ESIC MC and PGIMSR Rajajinagar Bangalore 560010 |
| Type of Sponsor |
Other [self] |
|
|
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 G S Proktha |
ESIC Medical College and Post Graduate Institute of Medical Science and Research |
2nd Floor OT Complex, Department Of Anaesthesiology
BANGALORE
Bangalore
KARNATAKA |
9494029506
gsproktha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Fiberoptic bronchoscopy |
Ballotability of cuff to be checked after intubation at 0 secs and confirming mid tracheal position of trachea using fiberoptic bronchoscope within 10 mins of safe apnea time |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical status 1 and 2 scheduled for elective surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Patients scheduled for emergency surgery
Patients with BMI more than 30
Patients with difficult airway
Patients with front of neck swelling
Patients with congenital facial and tracheal anomalies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.distance between endotracheal tube proximal cuff to vocal cord:4-5cms |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| safety of patients by confirming mid tracheal position of tube |
baseline |
|
|
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)
|
20/03/2025 |
| 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
|
After taking informed written consent patients who meet inclusion criteria will be included in the study.preparation of the patient for the general anaesthesia will be done as per Standard Institutional Protocol. After preoxygenation appropriate size ET tube is passed and cuff is inflated to maintain cuff pressure of 20-30cm of water and connected to ventilator .The tube is then held in position and cuff is palpated with gentle pressure and when cuff distension is measured maximally,Endotracheal tube is secured. Then Fiberoptic Bronchoscope is introduced and distance between proximal tube cuff to vocal cord and tube tip to carina is measured.The results are compared to mid tracheal position of tube i.e, 4-5cms from carina and 2-4 cms from vocal cord to proximal Margin of cuff.Observations will be analysed. |