| CTRI Number |
CTRI/2025/05/087642 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparison of efficacy of double lumen tube with EZ blockers for single lung ventilation. |
|
Scientific Title of Study
|
A comparative study to assess the efficacy of double lumen tube versus EZ-blockers for single lung ventilation in video-assisted thoracoscopic surgery .A randomized comparative prospective 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 |
Shilpa |
| Designation |
Professor |
| Affiliation |
sdm medical college |
| Address |
Anaesthesia Department,
SDM medical college , dharwad
Department of anaesthesia, sdm medical college, Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8970603987 |
| Fax |
|
| Email |
docshilpa04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
satish |
| Designation |
senior resident |
| Affiliation |
sdm medical college |
| Address |
Department of anaesthesia ,
sdm medical college , dharwad
KARNATAKA
580009
India |
| Phone |
8970603987 |
| Fax |
|
| Email |
pgmaraorao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
satish |
| Designation |
senior resident |
| Affiliation |
sdm medical college |
| Address |
Anaesthesia Department
sdm medical college , dharwad
Department of anaesthesia, adm medical college, Dharwad . 580009
Dharwad
KARNATAKA
580009
India |
| Phone |
8970603987 |
| Fax |
|
| Email |
pgmaraorao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sdm medical college Dharwad, karnataka. India 580003 |
|
|
Primary Sponsor
|
| Name |
satish kelageri |
| Address |
sdm medical college , dharwad, karnataka. 580009 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Meghana p Rao |
Sdm medical college and hospital,Dharwad, karnataka. 580009 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shilpa agnihotri |
Sdm medical college and hospital. |
Department of anaesthesia , sdm medical college and hospital, Dharwad ,karnataka 580009.
Dharwad
KARNATAKA |
9535879838
pgmaraorao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J90||Pleural effusion, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Double lumen tube. |
Patients assigned to the DLT group were intubated using Macintosh blade and a left-sided DLT
of an adequate size (37 Fr for women and 39 Fr for men). DLT was introduced into the trachea using conventional direct laryngoscopy. After passing the vocal cords, the
DLT was rotated 90degrees towards the left and advanced until
slight resistance was met.
Confirmation done by fiberoptic bronchoscopy and also any bronchial injuires were noted . Time to initial tube placement (ITP) was defined as the time from passing of the tube (DLT or EZB) past the vocal cords to satisfactory placement in the endobronchial lumen
has been achieved (DLT or EZB).
time required for bronchoscopy is defined as time from insertion of bronchoscope to confirmation of correct placement.
Malpositioning of DLTs confirmed by FOB after turning the patient to lateral position, non-operating lung on the dependent side. |
| Comparator Agent |
EZ blockers |
Patients assigned to the EZ group were intubated using a macintosh blade and conventional SLT of an
adequate size [7.5 mm intraluminal diameter (ID) for women
and 8.5 mm ID for men] using conventional direct laryngoscopy. The multiport adapter was placed on the SLT, andthe EZB was inserted through one of the two upper ports on
the multiport adapter with completely deflated cuffs. EZB was advanced until slight resistance was met, suggesting
the position between the end of the tracheal tube and the
main carina has been reached, with the two distal ends of
the EZB protruding into the left and right main bronchi. Time to initial tube placement noted and time required for bronchoscopy noted. Mispositioning of DLTs confirmed by FOB after turning the patient to lateral position.
During SLV, heart rate , blood pressure , saturation , ECG were monitored . pressure-controlled ventilation with a peak
pressure of 20–25 cm H2O and a PEEP of 5 cm H2O was
used on the dependent lung.
Initially, 100% oxygen was
used. As early as possible, oxygen in air (FIO2 ) was gradually
reduced by 10%. Where end-tidal carbon dioxide was stabilized at 35-45 mmhg and isoflurance with propofol infusion was used to maintain anaesthesia.
Surgeons rated the extent of collapse of the lung, which is relevant for performing atraumatic surgery as follows:
(1) excellent (complete collapse with perfect surgical
exposure),
(2) fair (total collapse, but still some residual air in the
lung), and
(3) poor (no collapse, or partial collapse with interference
in surgical procedure).
The use of this straightforward classification was based on a
previous study by Campos and Kernstine.[7]
The anesthetist performing the intubation evaluated their subjective feeling of difficulty in the use of the respective devices
(1, very easy; 2, easy; 3, medium; 4, worse; 5 impossible).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 18 years and less than 90 years
2. Elective VAT surgeries |
|
| ExclusionCriteria |
| Details |
1.BMI more than 45
2. Any contraindications against placing a DLT
3. Systemic infection |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To estimate the time for intubation procedure
2. Time to verify the correct position of EZB or DLT using fibreoptic bronchoscopy |
baseline, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To asses satisfactory lung collapse
2. Ease of insertion by anesthesiologist
3. Post operative hoarseness & sore throat |
baseline , 24 hours |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/05/2025 |
| 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="0"
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
|
Single lung ventilation is used for lung isolation techniques for patients undergoing thoracic, mediastinal, cardiac and thoracic surgeries. Double lumen tubes (DLT) are the most commonly used airway devices for thoracoscopic surgeries including video assisted thoracoscopic surgeries. After DLT, Bronchial blockers are the alternative devices used for thoracoscopic surgeries. Bronchial blockers will cause the blockade of one bronchus which will allow the lung to collapse The advantages of Bronchial blocker over DLTs are – mainly in difficult airways, tracheostomized patients, unplanned one lung ventilation and prolonged ventilation post-surgery. In this study we are comparing efficacy of DLT and Ez blocker in video assisted thoracoscopic surgeries for one lung ventilation which includes time taken for intubation, ease of intubation, airway pressures in supine and lateral, collapsibility of the lung and sore throat after 24hours. |