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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C349||Malignant neoplasm of unspecifiedpart of bronchus or lung, |
|
Intervention / Comparator Agent
|
|
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. |