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CTRI Number  CTRI/2024/04/065019 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of co2 on arterial oxygenation during one lung ventilation. 
Scientific Title of Study   A Randomized comparative study to compare the effect of normocarbia vs permissive hypercarbia on arterial oxygenation during one lung ventilation in lung surgeries at SMS medical college , jaipur 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Indu verma  
Designation  Senior professor  
Affiliation  Sms medical college , jIpur 
Address  Department of anaesthesia 2nd floor , Dhanwantri block Sms medical college, jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  94139622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Indu verma  
Designation  Senior professor  
Affiliation  Sms medical college , jIpur 
Address  Department of anaesthesia 2nd floor , Dhanwantri block Sms medical college, jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  94139622967  
Fax    
Email  dr.induverma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjana Kumari meena 
Designation  PG Resident 
Affiliation  Sms medical college 
Address  Department of anaesthesia 2nd floor Dhanwantri block Sms medical college, jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  7204223591  
Fax    
Email  anjanakumarimeena@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia 2nd floor Dhanwantri block, sms medical college jaipur 
 
Primary Sponsor  
Name  Sms medical college 
Address  Sms medical college and attached hospitals Jaipur 302004 
Type of Sponsor  Government medical college 
 
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 indu verma  Sms medical college, jaipur  Cardiac operation theater, 2nd floor, Department of anaesthesia 2nd floor Dhanwantri block Sms medical college jaipur
Jaipur
RAJASTHAN 
9413622967

dr.induverma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sms medical college and attached hospitals, jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hypercarbia   During one lung ventilation we will maintain permissive hypercarbia upto 50 by changing respiratory rate for 30minutes 
Comparator Agent  Normocarbia   We will maintain normocarbia during one lung ventilation by changing respiratory rate for 30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age above 18 years
ASA grade 1 to 3
Patients undergoing elective lung surgeries (thoracotomy, pneumonectomy, lobectomy, bilobectomy, segmentectomy etc.)
Patients who will give informed written consent 
 
ExclusionCriteria 
Details  1.Patient should not be a part of other study.
2.Non co-operative patient.
3 .Patient who presented with cardiac arrhythmias
4. History of heart failure, vascular disease, chronic obstructive pulmonary disease, restrictive pulmonary disease or increased increased intracerebral pressure
5. Evidence of any liver or kidney disease
6. Patients with haemostatic disorders
7. Previously existing chronic respiratory disease of non-operated lung
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean PaO2 in both study group.
Mean change in haemodynamic variables- HR,SBP,DBP,MAP
Mean change in respiratory variables - Pmean, Pplateau, dynamic compliance etc
 
Baseline , after 30 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in heamodynamic variables and respiratory variables   30 minutes  
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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   Phase 4 
Date of First Enrollment (India)   07/04/2024 
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="0"
Months="6"
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  

One lung ventilation has become accepted procedure where lung isolation and sepration is required in thoracic surgeries . During one lung ventilation (OLV) diseased lung  is  collapsed which is being operated while ventilation of the other lung is required to facilitate better  surgical access and visibility in  lung surgeries. We use double-lumen endotracheal tubes (DLT) or bronchial blocker for OLV.  This technique helps to prevent contamination of normal lung and improve surgical ability.

During one-lung ventilation (OLV)  the nonventilated lung remains perfused but not ventilated, leading to an increase in shunt fraction and a decrease in oxygenation. This obligatory intrapulmonary shunt may produce hypoxemia because of collapse of the nondependent lung and increased atelectatic areas in the dependent lung. It leads to ventilation -perfusion mismatch.

Hypoxic Pulmonary Vasoconstriction shunts divert blood away from poorly oxygenated areas to better ventilated lung segments, thereby optimizing ventilation-perfusion matching, reducing shunt fraction and optimizing systemic O2 delivery.

Oxygenation during OLV can be improved by increasing blood flow to the ventilated lung or decreasing blood flow to the nonventilated lung.

Carbon dioxide is a potent vasodilator in cerebral and systemic circulation. However the effect of CO2 on pulmonary circulation is unclear.

Permissive hypercapnia refers to the ventilator strategy that allows the Pco2 to rise in a controlled fashion in an effort to reduce lung injury and the burden of gas exchange. Although a Pco2 value of 40 mm Hg is considered normal in healthy humans, higher values may be adaptive in disease. Permissive hypercapnia can be achieved by reductions in respiratory rate or tidal volume, or both. 

In this study, we tested the hypothesis that   hypercarbia within permissible limits may have  effect in improving arterial oxygenation compared to normocarbia during OLV in patients undergoing lung surgeries.


 
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