| 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
|
|
|
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
|
|
|
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. |