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CTRI Number  CTRI/2016/02/006602 [Registered on: 03/02/2016] Trial Registered Retrospectively
Last Modified On: 19/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   An observational study to check whether diffrernce in the carbon dioxide exhaled from two lungs can predict intraoperative fall in blood oxygen levels during elective thoracic surgeries. 
Scientific Title of Study   A prospective, observational study to evaluate the usefulness of gradient of end tidal carbon dioxide between two lungs in supine and lateral position, to predict intraoperative hypoxemia during one lung ventilation, in 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 Aparna Chatterjee 
Designation  Associate Professor 
Affiliation  Tata Memorial Centre, Mumbai 
Address  Department of Anesthesiology, critical care and pain, 2nd floor, main building, Tata Memorial Hospital, Parel, Mumbai -400012
Department of Anesthesiology, critical care and pain, 2nd floor, main building, Tata Memorial Hospital, Parel, Mumbai -400012
Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax    
Email  aparnasanjay@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swapnil Y Parab 
Designation  Assistant Professor 
Affiliation  Tata Memorial Centre, Mumbai 
Address  Department of Anesthesiology, critical care and pain, 2nd floor, main building, Tata Memorial Hospital, Parel, Mumbai -400012

Mumbai
MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax    
Email  swapnil.parab@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swapnil Y Parab 
Designation  Assistant Professor 
Affiliation   
Address  Department of Anesthesiology, critical care and pain, 2nd floor, main building, Tata Memorial Hospital, Parel, Mumbai -400012


MAHARASHTRA
400012
India 
Phone  022-24177000  
Fax    
Email  swapnil.parab@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Tata memorial Hospital 
Address  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 Y Parab  Tata memorial Hospital, Mumbai  Thoracic Operation theatre, MB-210, Main OT Complex, Tata Memorial Hospital, Main building, Parel, Mumbai
Mumbai
MAHARASHTRA 		 022-24177053

swapnil.parab@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing elective thoracic surgeries requiring one lung ventilation with the use of double lumen tube,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patient undergoing thoracic surgery in lateral decubitus position requiring one lung ventilation (OLV) delivered by a double lumen tube (DLT) in whom arterial line has been inserted intraoperatively would be incorporated in the study.
 
 
ExclusionCriteria 
Details  • Age < 18 yrs
• Emergency Surgeries
• Surgeries using Bronchial blockers
• Patient with Tracheostomy
• Arterial line not cannulated at the start of surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The relationship between the values of gradient of EtCO2 between two lungs in supine and lateral position and PaO2/FiO2 ratio, obtained from aterial blood gas sample.  intraoperatively when the samples of arterial blood geses are analysed to note PaO2/FiO2 ratios.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/06/2015 
Date of Study Completion (India) 18/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Parab SY, Chatterjee A, Saxena RS. The utility of gradient of end-tidal carbon dioxide between two lungs in lateral decubitus position in predicting a drop in oxygenation during one-lung ventilation in elective thoracic surgery- A prospective observational study. Indian J Anaesth. 2021 Oct;65(10):744-749.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is an observational study to find out whether difference in the EtCO2 from two lungs in supine and lateral position, can be used to predict the intraoperative hypoxemia. In lateral position, there is gravitational distribution of blood flow to dependent lung, and blood flow to non-dependent lung is reduced. Hence, EtCO2s from two lungs would vary. during one lung ventilation, blood flow to the non-dependent lung becomes shunt. More the shunt, more the chances of intraoperative hypoxemia. Hence, gradient of EtCO2 between two lungs can predict intraoperative hypoxemia.  
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