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CTRI Number  CTRI/2021/10/037633 [Registered on: 27/10/2021] Trial Registered Prospectively
Last Modified On: 19/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Studying the prevalence of dysfunction of relaxation phase of left heart in critically ill patients admitted in ICU 
Scientific Title of Study   Prevalence of Diastolic Dysfunction in Critically Ill Patients Admitted to Critical Care Unit from a Tertiary Care Hospital- A Prospective Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bipin Luitel 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology, Second floor, Institute block, JIPMER, Dhanvanthri Nagar, Puducherry-605006

Pondicherry
PONDICHERRY
605006
India 
Phone  7209277938  
Fax    
Email  luitelbipin95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Senthilnathan Muthapillai 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology & Critical Care, Second floor, Institute Block, JIPMER, Dhanvantri nagar, Puducherry-605006
Department of Anaesthesiology & Critical Care, Second floor, Institute Block, JIPMER, Dhanvantri nagar, Puducherry-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  7598566983  
Fax    
Email  mmc.senthil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Senthilnathan Muthapillai 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anaesthesiology & Critical Care, Second floor, Institute Block, JIPMER, Dhanvantri nagar, Puducherry-605006
Department of Anaesthesiology & Critical Care, Second floor, Institute Block, JIPMER, Dhanvantri nagar, Puducherry-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  7598566983  
Fax    
Email  mmc.senthil@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri nagar, Puducherry-605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dhanvanthri Nagar, Puducherry-605006 
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 Bipin Luitel  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)  Department of Anaesthesiology & Critical Care, JIPMER, Dhanvantri nagar, Puducherry-605006
Pondicherry
PONDICHERRY 		 7209277938

luitelbipin@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  (1) ICD-10 Condition: J952||Acute pulmonary insufficiency following nonthoracic surgery, (2) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, (3) ICD-10 Condition: I210||ST elevation (STEMI) myocardial infarction of anterior wall, (4) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult patients (>18 years of age) admitted in ICU who are on mechanical ventilation for more than 48 hours (patients will be recruited for this study on the third day of mechanical ventilation)
 
 
ExclusionCriteria 
Details  Patients with pre-existing mitral valvular lesions
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the prevalence of Diastolic Dysfunction in adult patients requiring mechanical ventilation in ICU  After 48 hours of Mechanical Ventilation in ICU 
 
Secondary Outcome  
Outcome  TimePoints 
To study the incidence of the 28-days mortality among these patients  After 28 days of Mechanical Ventilation 
To study the incidence of weaning failure among these patients   Within 48 hours after extubation (requirement of any form of ventilatory support) 
To measure B-type Natriuretic Peptide (BNP) levels among these patients
 		 After 48 hours of Mechanical Ventilation 
 
Target Sample Size   Total Sample Size="227"
Sample Size from India="227" 
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)   15/11/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 Postgraduate Research Monitoring Committee and Institute Ethics Committee, this study will be registered in Clinical Trial Registry-India. Adult patients who are on mechanical ventilation for more than 48 hours in ICU will be recruited for this study after obtaining the informed written consent from the legally acceptable representative of the patient and from the patient who succeeded extubation, as early as possible (only in patients whose sensorium is intact enough to understand the conduct of this study in him/her and the informed written consent will be obtained by the researcher). Age, height, gender, diagnosis, reason for which patient has been placed on ventilator and Acute Physiology and Chronic Health Evaluation II (APACHE II) score on day 1 of admission in the CCU will be obtained. Sequential Organ Failure Assessment (SOFA) score will be obtained on the day of performance of the study. Presence of comorbid conditions (details of comorbid conditions will be obtained by history, previous medical records and by current investigations) like diabetes mellitus (DM), hypertension (HTN), coronary artery disease (CAD), dyslipidemia, congestive cardiac failure (CCF), chronic kidney disease (CKD), chronic obstructive pulmonary disease (COPD), hepatic cirrhosis and any arrhythmias will be noted. Patient’s heart rate (HR), oxygen saturation (SpO2), systolic, diastolic and mean arterial blood pressures (SBP, DBP and MAP) will also be recorded just before the measurement of the study parameters. Blood sample will be drawn while performing the study to measure B-type natriuretic peptide (BNP) level (BNP level will be measured only once for the purpose of this study). The settings for mechanical ventilation like mode of ventilation, tidal volume [per kg of Ideal Body Weight (IBW)], positive end expiratory pressure (PEEP) and fraction of inspiratory oxygen concentration will be decided as per the discretion of the attending intensivist and those parameters will be noted. Low frequency phased array probe (1-5 mHz, My LabX5, Esaote, Genova, Italy) will be used to record the study parameters. The study parameters will be recorded on the third day of mechanical ventilation in the CCU during a stable haemodynamic window. In this study, a stable haemodynamic window is defined as absence of administration of fluid boluses or change of vasopressor/inotropic agent dose for two hours period. An Intensivist who has experience in transthoracic echocardiography (TTE) at least for one year will record the study parameters. Apical four-chamber (A4C) view will be obtained by placing the echocardiographic probe over the apical impulse and by keeping the probe horizontally with orientation marker facing left side. Pulse wave Doppler sampling will be obtained at mitral valvular leaflet tips to obtain E wave which represents early passive diastolic filling and A wave that results from atrial contraction. Deceleration time will be obtained from E wave. The machine will calculate E/A ratio. Tissue Doppler Imaging (TDI) will be utilized to measure mitral annular peak velocities. Tissue Doppler sampling will be done at septal mitral annulus to obtain septal eËŠ; it will be done in lateral mitral annulus to obtain lateral eËŠ. The machine will calculate average E/eËŠ. Left atrial (LA) volume index will be obtained by measuring its length and transverse diameter in A4C or apical 2 chamber view, one to two frames prior to opening of the mitral valve. Tricuspid regurgitation maximum velocity will be obtained by placing the continuous wave Doppler at the regurgitant jet area (can be located by color flow Doppler) in A4C view. Patient’s systolic function of LV will be assessed by SËŠ velocity. The recommendation by American Society of Echocardiography will be utilized to look for the presence or absence of diastolic dysfunction (DD) and the grading of the DD. Weaning failure is defined as a requirement of any form of ventilatory support within 48 hours of extubation. Patient’s outcome (survival) at 28 days after the recruitment in this study will be noted.

 

 
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