CTRI Number |
CTRI/2025/04/083923 [Registered on: 02/04/2025] Trial Registered Prospectively |
Last Modified On: |
25/03/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Follow Up Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Assessment of breathing parameters using single-channelled breathing tube in surgeries for esophageal cancer |
Scientific Title of Study
|
A PROSPECTIVE STUDY ASSESSING VENTILATORY PARAMETERS WITH SINGLE LUMEN ENDOTRACHEAL TUBE IN VIDEO-ASSISTED THORACOSCOPIC OESOPHAGEAL ONCOLOGICAL SURGERIES |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
SANJANA S |
Designation |
SENIOR RESIDENT |
Affiliation |
KMC MANIPAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY, KMC MANIPAL
Udupi KARNATAKA 576104 India |
Phone |
09952612396 |
Fax |
|
Email |
sanjanasubbiah44@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SANJANA S |
Designation |
SENIOR RESIDENT |
Affiliation |
KMC MANIPAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY, KMC MANIPAL
Udupi KARNATAKA 576104 India |
Phone |
09952612396 |
Fax |
|
Email |
sanjanasubbiah44@gmail.com |
|
Details of Contact Person Public Query
|
Name |
SANJANA S |
Designation |
SENIOR RESIDENT |
Affiliation |
KMC MANIPAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY, KMC MANIPAL
Udupi KARNATAKA 576104 India |
Phone |
09952612396 |
Fax |
|
Email |
sanjanasubbiah44@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
SANJANA S |
Address |
DEPARTMENT OF ANAESTHESIOLOGY, KMC MANIPAL, UDUPI 576104
KARNATAKA, INDIA |
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 |
SANJANA S |
KASTURBA MEDICAL COLLEGE MANIPAL |
TIGER CIRCLE ROAD, MADHAV NAGAR, ESHWAR NAGAR, MANIPAL Udupi KARNATAKA |
09952612396
sanjanasubbiah44@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: C15||Malignant neoplasm of esophagus, (2) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Adult patients (18 years and above) who will undergo video-assisted thoracoscopic oncological oesophageal surgeries (CA stomach/ CA oesophagus) in the study period |
|
ExclusionCriteria |
Details |
VATS converted to open esophagectomy, pregnant women, persons with intellectual disabilities |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate mean tidal volume during one lung ventilation with single lumen tube during the period of capnothorax during VATS |
Beginning of surgery, After capnothorax initiation- 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, 210 min, End of surgery |
|
Secondary Outcome
|
Outcome |
TimePoints |
- To evaluate other ventilatory parameters during capnothorax with TLV in VATS
- To assess surgeons’ comfort in visibility during capnothorax
- To evaluate postoperative pulmonary complications within one week of surgery with TLV
|
Beginning of surgery, After capnothorax initiation- 0 min, 30 min, 60 min, 90 min, 120 min, 180 min, 210 min, End of surgery |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
14/04/2025 |
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
|
After obtaining approval from the Institutional Ethics Committee, patients with a known diagnosis of CA oesophagus/ stomach who are posted for VATS esophagectomy at our institution will be recruited. A written informed consent from the patient will be obtained and demographic information about each patient including age, sex, weight, and height will be obtained from the charts. On the day of the surgery, the patient will be induced as per the choice of the concerned anaesthesiologist. The initial ventilation mode shall be kept as pressure controlled to achieve tidal volume of 5 ml/kg. Respiratory rate shall be titrated to maintain ETCo2 between 35 and 45. Post induction, information such as the duration of surgery, approach (Ivor Lewis/ McKewon) ventilatory parameters (tidal volumes, respiratory rate, peak pressures, PEEP, compliance, FiO2, oxygen saturation, end-tidal carbon dioxide), capnothorax parameters (insufflation pressure, flow rate), surgeons’ comfort about visibility of structures by using a 5 point Likert scale, and post-operative events (ICU stay, respiratory complications within one-week prolonged hospital stay) will also be noted. |