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CTRI Number  CTRI/2019/08/020633 [Registered on: 08/08/2019] Trial Registered Prospectively
Last Modified On: 20/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   The effect of end of expiration Positive Pressure on Central Venous Pressure in patient with closed and open chest undergoing cardiac surgery 
Scientific Title of Study   Quantitative effect of Positive End Expiratory Pressure on Central Venous Pressure in patient with closed and open thorax 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Lalit Jha 
Designation  Junior resident 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Anaesthesiology and Critical Care, Old hospital Building, JIPMER, Dhanvantari Nagar, Puduchherry 605006, India

Pondicherry
PONDICHERRY
605006
India 
Phone  8130917933  
Fax    
Email  drlalitjha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suman Lata 
Designation  Additional Professor 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Anaesthesiology and Critical Care, Old hospital Building, JIPMER, Dhanvantari Nagar, Puduchherry 605006, India

Pondicherry
PONDICHERRY
605006
India 
Phone  9488830091  
Fax    
Email  sumanlatagupta13@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Lalit Jha 
Designation  Junior resident 
Affiliation  Jawaharlal institute of postgraduate medical education and research 
Address  Department of Anaesthesiology and Critical Care, Old hospital Building, JIPMER, Dhanvantari Nagar, Puduchherry 605006, India

Pondicherry
PONDICHERRY
605006
India 
Phone  8130917933  
Fax    
Email  drlalitjha@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal institute of postgraduate medical education and research, Dhanvantari Nagar, Puduchherry 605006, India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Jawaharlal institute of postgraduate medical education and research, Dhanvantari Nagar, Puduchherry 605006, India 
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 Lalit Jha  Jawaharlal Institute of Postgraduate Medical Education and Research  Anaesthesiology office, 2nd floor, hospital block, Department of Anaesthesiology and Critical Care, JIPMER, Dhanvantari Nagar, Puduchherry 605006, India
Pondicherry
PONDICHERRY 
8130917933

drlalitjha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, (2) ICD-10 Condition: I361||Nonrheumatic tricuspid (valve) insufficiency, (3) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Three different levels of Positive end expiratory pressures (0cm H2O, 5cm H2O and 10cm H2O)  Three different levels of Positive end expiratory pressure 0cm H2O, 5cm H2O and 10cm H2O will be applied. Each level of pressure will be applied for duration of 3 minutes before sternotomy and to the same patient after sternotomy, for duration of 3 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18-60 years undergoing elective cardiac surgery of American Society of Anaesthesiologists (ASA) physical status I, II and III 
 
ExclusionCriteria 
Details  1. Patient with preexisting history of chronic obstructive pulmonary diseases, acute respiratory distress syndrome, Emphysematous diseases, arrhythmias
2. Patient with documented Pulmonary vein stenosis, any obstruction at right ventricular outflow tract, pulmonary artery, pulmonary vein.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the quantitative effect of positive end expiratory pressure on change in central venous pressure in patients with closed thorax compared to open thorax in patient undergoing cardiac surgery.
 
Three different levels of positive end expiratory pressure (0 cm H2O, 5cm H2O and 10cm H2O) will be applied to the patient before sternotomy and after sternotomy. The central venous pressure will be measured following 2 min of application of positive end expiratory pressure at every 15 second for next 1 minute. The mean value of 4 readings obtained will be calculated and documented. 
 
Secondary Outcome  
Outcome  TimePoints 
a.To assess the quantitative effect of positive end expiratory pressure on different levels of baseline central venous pressure.
b. To compare the effect of increase in positive end expiratory pressure on change in central venous pressure in patients with or without tricuspid regurgitation. 
a.The baseline central venous pressure will be noted. The corresponding central venous pressure will be measured following 2 min of application of positive end expiratory pressures at every 15 second for next 1 minute.
b.The presence or absence of tricuspid regurgitation will be measured with transesophageal echocardiography before start of procedure. The corresponding central venous pressure will be measured.
 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2019 
Date of Study Completion (India) 31/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Positive end expiratory pressure (PEEP) is the positive pressure applied to lung alveoli causing it to remain distended at the end of expiration in mechanically ventilated patients. Positive end expiratory pressure decreases the work done in collapsing and distending alveoli at each cycle, ensuring maximum volume for ventilation and perfusion. The lungs and heart are enclosed in pleural cavity and pericardial cavity respectively within the large thoracic cavity, making each component interdependent on each other. The extrinsic positive airway pressure applied create pressure within the alveoli and pleural cavity which is subsequently transmitted to the adjacent structures causing increase in intra cardiac and large vessels intramural pressures. This pressure is being measured by comparing it to atmospheric pressure, called as Central Venous Pressure (CVP). 

Central venous pressure is an important indicator of volume status of patients. Application of positive end expiratory pressure is known to influence the measurement of Central Venous Pressure. Therefore, the exact volume status of the patient based on central venous pressure may be difficult to determine in patient with positive end expiratory pressure. Under mechanical ventilation, positive end expiratory pressure is known to increase the mean airway pressure in lung. Similarly, Central venous pressure being an intramural pressure of caval vein, is equal to transmural pressure when extramural pressure is zero as in case of 0 cm H­­2O positive end expiratory pressure during expiration. The increase in mean airway pressure in lung may have proportionate or variable effect on intramural pressure of great veins. The exact quantity of extramural pressure which may influence the intramural pressure in closed thorax has been found to be variable across the literature. Furthermore, in case with open thorax even with the application of positive end expiratory pressure, the extramural pressure is expected to remain zero. Previous studies reported variable effect of positive end expiratory pressure on central venous pressure in closed thorax. 

Therefore in this study, the effect of positive end expiratory pressure on Central venous pressure will be determined in same patient with closed and open thorax. In such a scenario, it may be possible to exactly quantify the effect of positive end expiratory pressure on Central venous pressure in closed thorax compared to open thorax and this will enable Central venous pressure monitoring more reliable for volume status in cardiac surgery patients. The study will further help in understanding the physiology of positive end expiratory pressure effect on Central venous pressure.

 
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