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CTRI Number  CTRI/2022/06/043592 [Registered on: 30/06/2022] Trial Registered Prospectively
Last Modified On: 01/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   USG OF LUNG FOR RECURITMENT ASSESSMENT IN ARDS WITH PRONE POSITION 
Scientific Title of Study   ULTRASONOGRAPHIC ASSESSMENT OF LUNG AERATION AND RECURITMENT WITH USE OF PRONE POSITION IN ARDS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AMIT KUMAR CHOUDHARY 
Designation  RESIDENT DRNB 
Affiliation  MANIPAL HOSPITALS 
Address  MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98,OLD AIRPORT ROAD, BENGALURU
MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98,OLD AIRPORT ROAD, BENGALURU 560017
Bangalore
KARNATAKA
560017
India 
Phone  9433759919  
Fax    
Email  drakchoudhary2018@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  JUSTIN GOPALDAS 
Designation  CONSULTANT 
Affiliation  MANIPAL HOSPITALS 
Address  MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98, OLD AIRPORT ROAD, BENGALURU 560017
MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98, OLD AIRPORT ROAD, BENGALURU 560017
Bangalore
KARNATAKA
560017
India 
Phone  8884132998  
Fax    
Email  justin.a.gopaldas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  AMIT KUMAR CHOUDHARY 
Designation  RESIDENT DRNB 
Affiliation  MANIPAL HOSPITALS 
Address  MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98, OLD AIRPORT ROAD, BENGALURU 560017
MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98, OLD AIRPORT ROAD, BENGALURU 560017
Bangalore
KARNATAKA
560017
India 
Phone  9433759919  
Fax    
Email  drakchoudhary2018@gmail.com  
 
Source of Monetary or Material Support  
MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE 98, OLD AIRPORT ROAD BANGALORE - 560017 
 
Primary Sponsor  
Name  MANIPAL HOSPITAL 
Address  MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE MEDICINE 98 OLD AIRPORT ROAD, BENGALURU 560017 
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 
AMIT KUMAR CHOUDHARY  MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE  MANIPAL HOSPITAL DEPARTMENT OF CRITICAL CARE 98 OLD AIRPORT ROAD, BENGALURU 560017
Bangalore
KARNATAKA 
9433759919

drakchoudhary2018@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Manipal Hospitals, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J80||Acute respiratory distress syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ARDS patients with moderate to severe ARDS (fulfill the 2011 Berlin definition of ARDS) 
 
ExclusionCriteria 
Details  (i) Patients with massive subcutaneous emphysema or dressings in the examining area,
(ii) Patients who do not resuscitate orders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate alteration in lung density with the help of LUS and its correlation with oxygenation and outcomes in patients with ARDS.  First Prone to Supine position 28 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in lung aeration with LUS in patients with ARDS  During Supine and Prone Position 
Correlate change in oxygenation with changes in lung aeration.  24-28 hrs 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/06/2022 
Date of Study Completion (India) 28/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION AND NEED FOR THE STUDY

Acute respiratory distress syndrome (ARDS), characterized by increased lung weight and loss of lung aeration, is a life-threatening condition. According to the recently published literature, significant mortality reduction in ARDS patients have been obtained when prone position (PP)is utilized as an adjunct to lung protective ventilation.

Lung Ultrasound

Lung ultrasound has become an attractive new tool for assessing lung status in ventilated critically ill patients, as suggested by the increasing number of articles written about it by physicians practicing in chest, intensive care or emergency medicine. As a matter of fact, chest ultrasound can be used easily at the bedside to assess initial lung morphology in severely hypoxemic patients and can be easily repeated, allowing the effects of therapy to be monitored. Lung ultrasound (LUS) has been proposed as an alternative bedside imaging technique. Ex vivo, LUS artifacts changed with the progressive increase in lung density. In a controlled human model of lung air content variation, LUS reliably recorded the changes in lung aeration.

In this prospective, cross-sectional, observational study we will evaluate a sample size of 50 patient admitted in ICU as moderate to severe ARDS with aim to evaluate alteration in lung density with the help of LUS and its correlation with oxygenation and outcomes in patients with ARDS. Our Objective of this study will be to assess changes in lung aeration with LUS in patient with ARDS and correlate change in oxygenation in lung aeration.

LUS will be performed according to international guidelines. We will used 1–5 MHz convex probes. All intercostal spaces of the upper and lower parts of the anterior, lateral, and posterior areas of the left and right chest wall will be examined. (Figure 1) Four LUS exams will be performed for each patient 1 h before and after each reversal. Data will be collected 1 h before PP(LUS 1), 1 h after PP (LUS 2), 1 h before the patient was turned back to the supine position (LUS 3), and 1 h after the patient was returned to the supine position (LUS 4).

So all the data collected will be evaluated and statistical analysis will be done by an independent statistician.


 
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