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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  
DR SANJANA S 
 
Primary Sponsor  
Name  SANJANA S 
Address  DEPARTMENT OF ANAESTHESIOLOGY, KMC MANIPAL, UDUPI 576104 KARNATAKA, INDIA 
Type of Sponsor  Other [self] 
 
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 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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