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CTRI Number  CTRI/2025/02/079942 [Registered on: 04/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   Using Ultrasound to study How a Certain Breathing Treatment Affects the Lungs-A comparison of two methods. 
Scientific Title of Study   Ultrasonographic Evaluation of Positive End-Expiratory Pressure–induced Lung Recruitment: Comparison with the Recruitment-to-Inflation Ratio 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Version 2.0, Dated 25/12/2024  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr G Akhila 
Designation  DrNB Critical Care Medicine Resident 
Affiliation  Narayana Health 
Address  Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Dept of Critical Care Medicine, Narayana Health City, Bommasandra

Bangalore
KARNATAKA
560099
India 
Phone  9440257664  
Fax    
Email  akhila3488@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jose Chacko 
Designation  Senior Consultant, Department of Critical Care Medicine 
Affiliation  Narayana Health 
Address  Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Dept of Critical Care Medicine, Narayana Health City, Bommasandra

Bangalore
KARNATAKA
560099
India 
Phone  9844143041  
Fax    
Email  chackojose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jose Chacko 
Designation  Senior Consultant, Department of Critical Care Medicine 
Affiliation  Narayana Health 
Address  Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Dept of Critical Care Medicine, Narayana Health City, Bommasandra


KARNATAKA
560099
India 
Phone  9844143041  
Fax    
Email  chackojose@gmail.com  
 
Source of Monetary or Material Support  
Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra, Bengaluru ,India , 560099 
 
Primary Sponsor  
Name  Dr G Akhila 
Address  Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra 
Type of Sponsor  Other [Self] 
 
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 G Akhila  Mazumdar Shaw Medical Centre   Medical Intensive Care Unit, 2nd floor, Dept of Critical Care, Narayana Health City, Bommasandra, 560099
Bangalore
KARNATAKA 
9440257664

akhila3488@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee  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, (2) ICD-10 Condition: J81||Pulmonary edema, (3) ICD-10 Condition: J189||Pneumonia, unspecified organism, (4) ICD-10 Condition: J981||Pulmonary collapse,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. ARDS by Berlin criteria
2. Pulmonary oedema
3. Lung collapse
4. Lung consolidation 
 
ExclusionCriteria 
Details  1. Hemodynamic instability, with the use of norepinephrine more than 0.2 mcg/kg/min or an equivalent dose of other vasoactive agents (epinephrine more than 0.2 mcg/kg/min, dopamine more than 5 mcg/kg/min, vasopressin more than 0.01 units/min)
2. Decompensated heart failure
3. Raised intracranial pressure (ICP)
4. Presence of pneumothorax
5. Chronic obstructive pulmonary disease
6. Emphysematous lung
7. Patients on end-of-life care
8. Pregnancy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of lung ultrasonography in assessing lung recruitability and determining the
optimal PEEP (Positive End-Expiratory Pressure) settings based on recruitment assessment. 
Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate regional lung recruitment assessed through ultrasonography with the Recruitment/Inflation (R/I) ratio and use both techniques to identify hyperinflation, aiming to optimize PEEP levels in mechanically ventilated patients with severe hypoxia.  Baseline 
 
Target Sample Size   Total Sample Size="27"
Sample Size from India="27" 
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)   12/02/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Application of an optimal level of positive end-expiratory pressure (PEEP) is a crucial facet of optimizing mechanical ventilation among hypoxic patients. PEEP titration is usually guided by improvement in oxygenation and increase in the static compliance. The ARDSNet table recommends PEEP levels based on the FiO2 requirement. There are drawbacks associated with these methods of PEEP titration. The PaO2 levels may rise with an increase in the PEEP level due to reduced right-left shunt in the lung, unrelated to the extent of recruitment. Besides, alveolar recruitment may not always lead to improved lung compliance. Ultrasonography enables direct visualization of the extent of lung recruitment on application of incremental levels of PEEP. However, hyperinflation of the relatively normal lung cannot be identified by ultrasonography. The recruitment to inflation ration (R/I) evaluates lung compliance at a high and a low level of PEEP and compares the lung compliance at both levels. The R/I ratio may be a predictor of hyperinflation in the relatively normal lung.

Patients with acute hypoxemic respiratory failure with potentially recruitable lungs on mechanical ventilation in the MICU. Its Prospective observational study and aim of the study is to Evaluate the efficacy of bedside lung ultrasonography to assess lung recruitment – correlate with the Recruitment/Inflation (R/I) ratio as a technique to identify hyperinflation of normal lungs.

 
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