| CTRI Number |
CTRI/2025/07/090598 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of correct placement of endobronchial blocker (EZ-Blocker) vs. Double-Lumen Tube for patients requiring One-Lung ventilation When Inserted Without the aid of a bronchoscope |
|
Scientific Title of Study
|
EZ- blocker (Rusch) versus Robert Shaw double lumen tube: Efficacy of correct
placement with blind insertion technique (without the use of fibre optic
bronchoscope) to achieve appropriate one lung ventilation |
| 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 Davinder Jit Singh |
| Designation |
Assistant professor |
| Affiliation |
Command hospital southern command pune |
| Address |
Department of Anaesthesiology and Critical care,Fifth Floor Block-B5, Room 531, Command hospital southern command, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8728055241 |
| Fax |
|
| Email |
davinderjit98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Davinder Jit Singh |
| Designation |
Assistant professor |
| Affiliation |
Command hospital southern command pune |
| Address |
Department of Anesthesiology and Critical Care, Fifth floor, block B5, Room no 531, Command hospital southern command, Pune
MAHARASHTRA
411001
India |
| Phone |
8728055241 |
| Fax |
|
| Email |
davinderjit98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Davinder Jit Singh |
| Designation |
Assistant professor |
| Affiliation |
Command hospital southern command pune |
| Address |
Department of Anaesthesiology and Critical care, Fifth Floor, Block B5, Room no 531,Command hospital southern command, Pune
MAHARASHTRA
411001
India |
| Phone |
8728055241 |
| Fax |
|
| Email |
davinderjit98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office of Director General Armed Forces Medical Services (DGAFMS), Ministry of Defence, 5th floor of A block, Defence Officers Complex,Africa Avenue,New Delhi, India Pincode 110023 |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Services |
| Address |
Directorate general Armed Forces Medical Services (DGAFMS),5th Floor, A block,Defence Officers Complex, Africa Avenue, New Delhi, Pin 110023 |
| Type of Sponsor |
Other [Army Medical Corps] |
|
|
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 |
| DAVINDER JIT SINGH |
Armed Forces Medical College, Command Hospital Southern Command |
Department of Anaesthesiology and Critical Care, 5th Floor, Block 3 to5,
Pune
MAHARASHTRA |
08728055241
davinderjit98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, Armed Forces College, Solapur Road Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, (2) ICD-10 Condition: I278||Other specified pulmonary heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EZ endobronchial blocker |
EZ endobronchial blocker will be placed with blind insertion technique, without use of fibre optic bronchoscope to achieve one lung ventilation. placement eill be finally confirmed with auscultation and fibreoptic bronchoscope. Time points- 1. Post insertion of the EZ blocker. 2- Post patient positioning, Hemodynamics will be monitored -timepoints- . T0 baseline, T1- post induction, T2- during laryngoscopy and intubation, T3 at 15 min post intubation |
| Comparator Agent |
robert shaw double lumen tube |
robert shaw double lumen tube will be inserted under direct laryngoscopy and placement confirmed clinically and with fibre optic bronchoscope.Time points- 1. Post insertion of the EZ blocker. 2- Post patient positioning, Hemodynamics will be monitored -timepoints- . T0 baseline, T1- post induction, T2- during laryngoscopy and intubation, T3 at 15 min post intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing surgery requiring one lung ventilation |
|
| ExclusionCriteria |
| Details |
1. patients with anticipated difficult airway
2. pre existing severe systemic disease (ASA 4 and above)
3. thoracic surgery within the last 4 weeks |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess success rate in correct placement of EZ blocker and double lumen tube, with blind insertion technique by comparing number of attempts, time taken and fibre optic bronchoscopy |
Time points for correct placement post blind insertion a check bronchoscopy will be done at - 1. Post insertion of the EZ blocker. 2- Post patient positioning.
Hemodynamics will be monitored -timepoints- . T0 baseline, T1- post induction, T2- during laryngoscopy and intubation, T3 at 15 min post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare changes in heart rate, blood pressure and episodes of desaturation |
baseline, during insertion and 15 min post insertion of device |
|
|
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)
|
31/07/2025 |
| 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 Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [davinderjit98@gmail.com].
- For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Double lumen
tubes(DLT) and bronchial blockers (BBs) have
traditionally been used for one lung ventilation. While insertion of DLT
is technically difficult; BBs have been easier to use, but they require
frequent repositioning. Blockers also cause less intubation related
post-operative complications (sore thro at, hoarseness of voice) and negate the
need to change the DLT to a single lumen tube at the end of surgery. Fibre
optic bronchoscopy is recommended to confirm the correct placement; more so,
for the DLT owing to its larger lumen. EZ blocker is a semi-rigid
catheter with two distal extensions, inflatable balloons and anchors itself on
the carina. It is hypothesised to be easier to introduce than DLT, even without
an FOB aid. The aim of our study is to assess the safety and
efficacy of inserting this novel blocker without use of FOB and compare it with
DLT insertion with similar technique. |