Studying the prevalence of dysfunction of relaxation phase of left heart in critically ill patients admitted in ICU

Not yet recruiting

Conditions: 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,

Registration Number: CTRI/2021/10/037633

Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research

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. Patientâ€™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. Patientâ€™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. Patientâ€™s outcome (survival) at 28 days after the recruitment in this study will be noted.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 227

Inclusion Criteria

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).

Exclusion Criteria

Patients with pre-existing mitral valvular lesions.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳
Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
🇮🇳Pondicherry, PONDICHERRY, India
Dr Bipin Luitel
Principal investigator
7209277938
luitelbipin@gmail.com