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CTRI Number  CTRI/2023/03/050319 [Registered on: 03/03/2023] Trial Registered Prospectively
Last Modified On: 27/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study to check the efficacy of right-sided double lumen tube in surgeries of thoracic region.  
Scientific Title of Study   A prospective observational study to assess the safety and efficacy following the use of the right-sided double-lumen tubes for elective thoracic surgeries.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swapnil Parab 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesiology, Tata Memorial Hospital, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  swapnil.parab@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swapnil Parab 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesiology, Tata Memorial Hospital, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  swapnil.parab@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Urvashi Lohiya 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Dept of Anesthesiology, Tata Memorial Hospital, Mumbai-400012

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177000  
Fax    
Email  urvashilohiya@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E Borges Road, Parel, Mumbai 400012 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swapnil Parab  Tata Memorial Hospital, Mumbai  Major operation theatre, 2nd floor, Main building, Tata Memorial Hospital, Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177000

swapnil.parab@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All adult patients undergoing one-lung ventilation using right-sided DLTs placed in the right main bronchus.  
 
ExclusionCriteria 
Details  1. Emergency surgery
2. Patient < 18 years of age
3. Endobronchial masses inside the trachea, right mainstem bronchus (RMB), or bronchus intermedius (BI)
4. Radiological evidence of compression or deviation of the trachea, RMB, or BI.
5. Patients planned for right pneumonectomy/right bronchial sleeve surgery or right bronchotomy.
6. Patient with anatomical variation in the trachea e.g. Pig Bronchus
7. Patients with a height of less than 150 cm
8. Patients with tracheostomy or anticipated difficult airway
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The incidence of intra-operative hypoxia associated with the use of Right-sided double lumen tube  at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the beginning of one-lung ventilation. 
 
Secondary Outcome  
Outcome  TimePoints 
the time taken for the insertion of RDLT, number of attempts of intubation, rate of first attempt success, and rate of dislodgement of RDLT  at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after the beginning of one-lung ventilation.  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="81" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/03/2023 
Date of Study Completion (India) 24/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

One-lung ventilation is a procedure where one of the two lungs is ventilated while the other one is not ventilated. It facilitates minimally invasive surgery. Double-lumen tubes (DLTs) are the most commonly used devices for one-lung ventilation. Both right and left-sided DLTs are available. However, left-sided DLTs are commonly used as Right-sided DLTs carry a risk of lack of ventilation to the upper part of the right lung. It leads to a drop in the level of oxygen in the blood. However, with the use of pediatric bronchoscopes, it is now possible to avoid this complication during surgery by achieving the correct position of the right-sided DLTs.

Hence, we wish to do a prospective, observational study to know the safety and efficacy associated with right-sided DLTs.

Written informed consent will be taken a day prior to surgery.

 

We will observe the process of insertion of right-sided DLTs, the incidence of intraoperative drop in the oxygenation, and the postoperative complications related to the lungs. 

 

The patient will be followed up from the day of surgery till discharge from the hospital for any post-operative pulmonary complications. 

There is no risk involved to the patient by participating in the study, as it is a purely observational study.

The patient’s identity will be kept confidential throughout the study.

The patient can withdraw from the study at any point in time. The clinical management of the patient won’t be affected by the decision to participate or withdraw from the study.  

 
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