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CTRI Number  CTRI/2023/07/055469 [Registered on: 21/07/2023] Trial Registered Prospectively
Last Modified On: 20/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [PEEP]  
Study Design  Single Arm Study 
Public Title of Study   Lung recruitment using ultrasonography 
Scientific Title of Study   Ultrasonographic Evaluation of Positive End-Expiratory Pressure–induced Lung Recruitment: Correlation with the Recruitment-to-Inflation Ratio  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NHH/AEC-CL-2023-992 version 1.0 dated 22/04/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jose Chacko 
Designation  Senior Consultant 
Affiliation  Narayana Health City 
Address  2 nd floor, Medical ICU, Mazumdar shaw buliding, Narayana Health City, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9844143041  
Fax    
Email  chackojose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jose Chacko 
Designation  Senior Consultant 
Affiliation  Narayana Health City 
Address  2 nd floor, Medical ICU, Mazumdar shaw buliding, Narayana Health City, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9844143041  
Fax    
Email  chackojose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jose Chacko 
Designation  Senior Consultant 
Affiliation  Narayana Health City 
Address  2 nd floor, Medical ICU, Mazumdar shaw buliding, Narayana Health City, Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9844143041  
Fax    
Email  chackojose@gmail.com  
 
Source of Monetary or Material Support  
2 nd floor, Medical ICU, Mazumdar shaw buliding, Narayana Health City, Bangalore 
 
Primary Sponsor  
Name  None 
Address  not applicable 
Type of Sponsor  Other [nil] 
 
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 Jose Chacko  Narayana Health City  2 nd floor, Medical ICU, Mazumdar shaw buliding, Narayana Health City, Bangalore
Bangalore
KARNATAKA 
09844143041

chackojose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health academic ethical comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  incremental PEEP for 25 minutes  Serial Positive end expiratory pressure from 5 to 10 and then to 15 is done and Lung ultrasound scores are measured along with abg. The duration of applied maneouvre is 25 minutes. it will be done only once per patient. 
Comparator Agent  Not applicable  Not applicable to our study. no comparator. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) ARDS by Berlin definition
2) Pulmonary edema
3) Lung collapse
4) Lung consolidation
 
 
ExclusionCriteria 
Details  1) Hemodynamic instability, with the use of norepinephrine >0.2 mcg/kg/min or an equivalent dose of other vasoactive agents (epinephrine >0.2 mcg/kg/min, dopamine >5 mcg/kg/min, vasopressin >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 
correlate recruitability between Lung USG & R/I ratio  PEEP recruitment will be performed only once within 48 hours of ventilation 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between delta aeration score & R/I ratio
Correlation between Re-aeration score and R/I ratio
Correlation between P/F ratio and delta aeration score
Correlation between P/F ratio and reaeration score
Correlation between P/F ratio and R/I ratio

In patients who have spontaneous respiratory efforts only the following scores will be recorded

Delta aeration score and P/F ratio
Reaeration score and P/F ratio
 
5 min, 10 min, 25 mins 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   31/07/2023 
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="0"
Months="6"
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  

. Background and Introduction

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 (1). The ARDSNet table recommends PEEP levels based on the FiO2 requirement (2). 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 (3). Besides, alveolar recruitment may not always lead to improved lung compliance (4). 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 (5,6).

 

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 (7).

 

 

2. Objectives of the study : We aim to evaluate lung recruitment by lung ultrasonography and the R/I ratio and correlate recruitability assessed using both techniques. We propose to conduct this pilot study to evaluate the feasibility of performing a larger, multicentric study on the use of ultrasonography to evaluate the potential for lung recruitment, while minimizing the risk of hyperinflation.

 

 

3. Eligibility criteria and participant recruitment procedure : Consecutive mechanically ventilated patients with focal or diffuse lung pathology including collapse, consolidation, acute respiratory distress syndrome (ARDS), and cardiogenic pulmonary edema with the potential for lung recruitment. Diagnosis of ARDS will be based on the Berlin criteria. Patients shall be enrolled within 48 hours of admission to the ICU.

 

 

4. Methodology –

1. Lung ultrasonography

 

An observer with more than 2 years ICU experience and performed lung ultrasonography on more than 20 patients shall assess lung recruitability. A 5 mHz curvilinear or a 8 mHz microconvex probe will be used for ultrasonographic imaging depending on the body habitus. The observer will record the lung aeration score based on the assessment described by Bouhemad et al. (5), at each incremental level of PEEP from 5 cm H2O to a maximum level of 15 cm H2O. Ventilation will be continued at each incremental level of PEEP for 5 minutes.

 

The aeration score, the delta aeration score, and the re-aeration score in each zone will be recorded at each level of PEEP.

 

2. The recruitment to inflation (R/I) ratio

 

The procedure involves the following steps:

 

1.      Switch to volume controlled – assist controlled mode (VC-AC) using the same set tidal volume and PEEP of 5 cm H2O

Reduce the frequency to 8 breaths/min, ensure that there is an end-inspiratory pause of 0.3 seconds by adjusting the inspiratory flow (for a maximum of 5 breaths). The inspiratory pause allows continuous measurement of plateau pressure (Pplat). Record the PEEP level, and the Pplat. Switch back to the previous ventilator settings.

 

2.      Increase the PEEP to 15 cm of H2O and continue ventilation for 20 minutes. Switch to (VC-AC) using the same set tidal volume. Reduce the frequency to 8 breaths/min with an end-inspiratory pause of 0.2 seconds by adjusting the flow (for a maximum of 5 breaths). This procedure enables continuous measurement of Pplat. Drop the PEEP level to 5 cm H2O. As the PEEP is reduced from 15 to 5 cm H2O, a large release volume is observed for the next breath. Record the release volume and the steady-state expired tidal volume at PEEP of 5 cm H2O.

 

Switch back to the baseline ventilator settings.

 

The R/I ratio calculation is based on the following equation.

 

Crec = ∆Vrec / (PEEP high – PEEP low) (1)

 

(Crec = compliance of the recruited lung; ∆Vrec = change in lung volume)

 

R/I ratio = Crec / Crs at low PEEP (2)

 

(Crs = respiratory system compliance)

 

The online tool available at www.rtmaven.com will be used to calculate the R/I ratio.

 

5. Risk and Benefits :

Benefits:

i.         assessment of lung recruitability

ii.       Titration of PEEP levels

iii.     Improvement of oxygenation

iv.      Reduction of driving pressure

v.       Reduction of VILI

 

Risks:

vi.      Hemodynamic instability

vii.    Barotrauma

6. Obtaining Informed consent Form: Y

7. Statistical Analysis  :

Correlation between delta aeration score and R/I ratio

Correlation between Re-aeration score and R/I ratio

Correlation between P/F ratio and delta aeration score

Correlation between P/F ratio and reaeration score

Correlation between P/F ratio and R/I ratio

 

In patients who have spontaneous respiratory efforts only the following scores will be recorded

 

Delta aeration score and P/F ratio

Reaeration score and P/F ratio

 

All statistical analysis will be performed using MedCalc Version 20.218.

 

 

8. Confidentiality of the study participants : Y

9. Ethical Consideration : none

 

10. References :

 

1.  Maggiore SM, Jonson B, Richard JC, Jaber S, Lemaire F, Brochard L. Alveolar derecruitment at decremental positive end-expiratory pressure levels in acute lung injury: comparison with the lower inflection point, oxygenation, and compliance. Am J Respir Crit Care Med. 2001 Sep 1;164(5):795–801.

2.  Brower RG, Lanken PN, MacIntyre N, Matthay MA, Morris A, Ancukiewicz M, et al. Higher versus lower positive end-expiratory pressures in patients with the acute respiratory distress syndrome. N Engl J Med. 2004 Jul 22;351(4):327–36.

3.  Delong P, Murray JA, Cook CK. Mechanical ventilation in the management of acute respiratory distress syndrome. Semin Dial. 2006;19(6):517–24.

4.  Hess DR. Recruitment Maneuvers and PEEP Titration. Respir Care. 2015 Nov 1;60(11):1688–704.

5.  Bouhemad B, Brisson H, Le-Guen M, Arbelot C, Lu Q, Rouby JJ. Bedside ultrasound assessment of positive end-expiratory pressure-induced lung recruitment. Am J Respir Crit Care Med. 2011 Feb 1;183(3):341–7.

6.  Chiumello D, Mongodi S, Algieri I, Vergani GL, Orlando A, Via G, et al. Assessment of Lung Aeration and Recruitment by CT Scan and Ultrasound in Acute Respiratory Distress Syndrome Patients. Crit Care Med. 2018 Nov;46(11):1761–8.

7.  Stevic N, Chatelain E, Dargent A, Argaud L, Cour M, Guérin C. Lung Recruitability Evaluated by Recruitment-to-Inflation Ratio and Lung Ultrasound in COVID-19 Acute Respiratory Distress Syndrome. Am J Respir Crit Care Med. 2021 Apr 15;203(8):1025–7.

8.  Mercat A, Richard JCM, Vielle B, Jaber S, Osman D, Diehl JL, et al. Positive end-expiratory pressure setting in adults with acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):646–55.

9.  Meade MO, Cook DJ, Guyatt GH, Slutsky AS, Arabi YM, Cooper DJ, et al. Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial. JAMA. 2008 Feb 13;299(6):637–45.

10.       Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, et al. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178–87.

11.       Pan C, Chen L, Lu C, Zhang W, Xia JA, Sklar MC, et al. Lung Recruitability in COVID-19-associated Acute Respiratory Distress Syndrome: A Single-Center Observational Study. Am J Respir Crit Care Med. 2020 May 15;201(10):1294–7.

 

               

 
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