| CTRI Number |
CTRI/2024/05/067112 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of one lung ventilation versus two lung ventilation in esophageal surgeries |
|
Scientific Title of Study
|
Comparison of effect of one lung ventilation(OLV) Vs two lung ventilation(TLV) in video-assisted thoracoscopic (VATS) esophagectomy: An observational study |
| Trial Acronym |
VATS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant K Desai |
| Designation |
MD Student |
| Affiliation |
Kidwai Memorial Institute of Oncology, Bangalore |
| Address |
Kidwai Memorial Institute of Oncology, Department of Anesthesiology and Pain Relief, Major OT Block, Room no 105, Dr M H Marigowda road Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
7406844905 |
| Fax |
|
| Email |
prashantkdesai12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha Lakshman |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology, Bangalore |
| Address |
Department of Anesthesiology and Pain Relief, Major OT Block, Room no 105, Kidwai Memorial Institute of Oncology, Dr M H Marigowda road Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9480333357 |
| Fax |
|
| Email |
drkavithalakshman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavitha Lakshman |
| Designation |
Associate Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology, Bangalore |
| Address |
Department of Anesthesiology and Pain Relief, Major OT Block, Room no 105, Kidwai Memorial Institute of Oncology, Dr M H Marigowda road Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9480333357 |
| Fax |
|
| Email |
drkavithalakshman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute of Oncology, Dr M H Marigowda Road, Bangalore 560029 |
|
|
Primary Sponsor
|
| Name |
Dr Prashant K Desai |
| Address |
No 9,1, First Cross, Chaitanya Layout, Off Brookes Heaven Layout, JP Nagar 8th Phase, Bangalore, pincode 560078 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Prashant K Desai |
Kidwai Memorial Institute of Oncology, Bangalore |
Department of Anesthesiology and Pain Relief, OT Block, Room no 105, Dr M H Marigowda Road, Bangalore 560029
Bangalore
KARNATAKA |
7406844905
prashantkdesai12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE, KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C159||Malignant neoplasm of esophagus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients consenting to the study who are undergoing VATS surgery.
2. Adult patients between 18 and 60 years of age, of either sex.
3. ASA I & II patients.
|
|
| ExclusionCriteria |
| Details |
1. Patients not consenting to the study.
2. Patient with Restrictive Lung Disease.
3. ASA III and IV patients.
4. Cases converting VATS to open procedure.
5. Breath holding test less then 25 Second
6. Patient with asthma or chronic obstructive pulmonary disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.To Assess the ratio of PaO2 to fraction of inspired oxygen (PaO2/FiO2) |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To Assess PaO2, PaCO2 and surgical exposure.
2. To Assess the postoperative Inflammatory parameters like Body Temperature, Heart rate, Total leukocyte count, C reactive protein. |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/06/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a Prospective observational study, comparing the effects of one lung ventilation(OLV) Vs two lung ventilation(TLV) in video assisted thoracoscopic(VATS) esophagectomy.Group A: Patient with One lung Ventilation (OLV) using Single Lumen Tube (SLT) and Bronchial Blocker (BB) in Lateral Position. Group B: Patient with Two Lung Ventilation (TLV) using SLT in Prone Position. After Positioning the patient, in Group A Lateral Position and In Group B Prone Position, Arterial blood gas analysis will be done for the following parameters, partial pressure of oxygen (PaO2), partial pressure of carbon dioxide (PaCO2) and (Pao2/Fio2 ratio), the ratio of PaO2 to fraction of inspired oxygen, will be measured during pre-insufflation (T1), post insufflation (20 minutes) (T2), and in the interval of 1hr (T3), 2hr (T4), 3hr (T5) intraoperatively followed by 24hr (T6), and 48hr (T7) Postoperatively. Intraoperatively episodes of desaturation with duration and action taken for the same will also be noted. Patient will be monitored throughout the surgery as per standard protocol and patient will be shifted to ICU for further monitoring. For secondary outcomes, Postoperative inflammatory parameters like body temperature, heart rate, C-reactive protein, and Total leukocyte counts will be assessed after immediate post op and at an interval of 24hr and 48hr.
|