| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
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. |