| CTRI Number |
CTRI/2024/10/075502 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to determine reliability of ballotability of Endotracheal tube cuff to confirm mid tracheal position of tube using Fibreoptic bronchoscopy. |
|
Scientific Title of Study
|
Reliability of ballotability of endotracheal tube cuff to confirm mid tracheal position of tube correlating Fiberoptic bronchoscope- a crossectional 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 VATSAL SINGLA |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
ESI-PGIMSR BASAIDARAPUR,NEW DELHI |
| Address |
Room no. 2210, Department of Anaesthesiology, 2nd floor, OT Complex, ESI Basaidarapur, Ring road, West Delhi, New Delhi,110015
West
DELHI
110015
India |
| Phone |
9818423678 |
| Fax |
|
| Email |
vatsalsingla90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRASAD CGS |
| Designation |
H.O.D, Dept of Anaesthesiology and critical care, ESI- PGIMSR Basaidarapur |
| Affiliation |
ESI-PGIMSR BASAIDARAPUR,NEW DELHI |
| Address |
Room no.2210,Department of Anaesthesiology, 2nd floor, OT Complex, ESI Basaidarapur, Ring road, West Delhi, New Delhi,110015
West
DELHI
110015
India |
| Phone |
9480616548 |
| Fax |
|
| Email |
prasad_cgs@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PRASAD CGS |
| Designation |
H.O.D,Dept of Anaesthesiology and critical care, ESI-PGIMSR Basaidarapur |
| Affiliation |
ESI-PGIMSR BASAIDARAPUR,NEW DELHI |
| Address |
Room no.2210,Department of Anaesthesiology, 2nd floor, OT Complex, ESI Basaidarapur,Ring road, West Delhi, New Delhi,110015
West
DELHI
110015
India |
| Phone |
9480616548 |
| Fax |
|
| Email |
prasad_cgs@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| ESI-Post Graduate Institute of Medical Sciences and Research,New Delhi-110015 |
|
|
Primary Sponsor
|
| Name |
ESI-Post Graduate Institute of Medical Sciences and Research,New Delhi-110015 |
| Address |
Basaidarapur, Ring road, west delhi-110015, India |
| 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 Vatsal Singla |
ESI-PGIMSR Basaidarapur,New Delhi |
Room no.2210,Dept.of Anaesthesiology,2nd floor,OT Complex,ESI Basaidarapur,ring road,West Delhi,New Delhi,110015
West
DELHI |
9818423678
vatsalsingla90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/2012/-PGIMSR (part II) |
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 |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA I AND II
ELECTIVE CASES UNDER GENERAL ANAESTHESIA |
|
| ExclusionCriteria |
| Details |
BMI more than 30 kg/m2
Difficult airway |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The mean distance from the tip of the tube to the carina when the ballotability of the endotracheal tube cuff is felt at the suprasternal notch |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The mean distance of vocal cords from the proximal end of the cuff
The mean distance from the angle of the mouth to the carina
The mean distance from the angle of the mouth to the vocal cords
The mean length of the tube at the angle of the mouth |
1 day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2024 |
| Date of Study Completion (India) |
01/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Aim is to confirm the reliability of mid tracheal position of the endotracheal tube when ballotability is felt at the suprasternal notch, with gold standard fiberoptic bronchoscope. Study is prospective crossectional observational study 43 patients will be enrolled for the study after inclusion and exclusion criteria Written informed consent will be taken from patients After intubation using generalized institutional protocol in a patient undergoing general anaesthesia for elective ot, ballotability of endotracheal tube cuff is checked at suprasternal notch by putting 2 fingers on the suprasternal notch and squeezing the pilot balloon. If ballotability of cuff is felt at suprasternal notch then fiberoptic bronchoscope (which is gold standard) is used to observe: 1) The distance from tip of tube to carina All the measurements observed will be noted Primary objective is to measure the distance from the tip of the endotracheal tube to the carina by fiberoptic bronchoscope when ballotability is positive at suprasternal notch.
|