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
|
|
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
|
|
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 HÂÂ2O 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. |