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CTRI Number  CTRI/2024/01/061347 [Registered on: 10/01/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational Study 
Study Design  Other 
Public Title of Study   A study to evaluate the amount of energy delivered in one minute to the patient by the ventilator in seriously ill patients 
Scientific Title of Study   Mechanical power of ventilation during invasive mechanical ventilation in critically ill patients – A prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4274_Version 1.1 dated 16.10.23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J V Divatia 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177041  
Fax    
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr J V Divatia 
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  02224177041  
Fax    
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Savan Pandey 
Designation  DM Post graduate resident 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8084554811  
Fax    
Email  savan.pandey@yahoo.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical Care and Pain, 2nd Floor Main Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E Borges Road Parel, Mumbai Pin 400012 
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 
Dr J V Divatia  Tata Memorial Hospital  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA 		 02224177041

jdivatia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II, Tata Memorial Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Age more than or equal to 18 years
2.All patients who are being mechanically ventilated in ICU
3.On volume controlled mode of ventilation with constant flow
4.Completely relaxed on mechanical ventilation or deeply sedated patients not triggering the ventilator at the time of data collection
 
 
ExclusionCriteria 
Details  1. Spontaneously breathing patient on mechanical ventilation
2. Pregnant patients
3. BMI more than or equal to 30
4. Post pneumonectomy or lobectomy patients
5. Palliative patient
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Descriptive analysis of Mechanical power being delivered to mechanically ventilated patients  Mechanical power calculation will be recorded soon after the patient is intubated and will be recorded every 6 hours until 96 hours or until the patient starts breathing spontaneously whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the association between mechanical power and mortality within 30 days from the start of invasive mechanical ventilation.
2. To assess association between mechanical power and ventilator free days till day 30.
3. To arrive at a threshold for mechanical power for predicting mortality. 		 At 30 days 
 
Target Sample Size   Total Sample Size="711"
Sample Size from India="711" 
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)   10/01/2024 
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)
Modification(s)  		 Other (Terminated) 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Introduction

 

Invasive Mechanical ventilation is a life-saving treatment to improve oxygenation, ventilation, lung recruitment and decrease work of breathing. However, over time it was realized that in addition to these beneficial effects, it also poses risk of damage to lungs called as ventilator induced lung injury or VILI. The risk of VILI depends on variables related to both ventilator and the lungs. Through experimental and observational studies it has been found that variables related to ventilator contributing to VILI in differing measures include tidal volume, driving pressure, PEEP, inspiratory flow rate and respiratory rate. These variables mostly have been studied independently as factors causing VILI. Gattinoni et al suggested that all the above mentioned variables causing VILI may be unified into a unique summary or composite variable called the Mechanical Power (MP). Mechanical power is the energy transferred from the ventilator to the respiratory system of the patient with each breath multiplied by respiratory rate, that is the energy transferred per minute. The association of trans-pulmonary MP with VILI was first established by Cressoni et al in a porcine study in 2016 (1)and this was later followed by multiple animal and human studies verifying the same.

 

The most precise way to measure mechanical power would be to measure the area under the inspiratory Pressure-volume curve. But this is not possible at the bedside since the area under the P-V curve isn’t generally bound by straight lines and will require special equipment or software addition to the ventilator to measure and solve for integral of airway pressure with respect to the change in volume. Secondly and more importantly, measurement of MP like this will not provide the composition and relative contribution of the individual variables that affect MP and hence may be altered at the bedside to change MP to prevent VILI. To solve this problem, Gattinoni et al invented an algebraic equation from the equation of motion for the respiratory system and validated it by establishing its correlation with measured MP for volume controlled ventilation with constant flow(2). Later, a simpler and easier surrogate equation was proposed and validated by Giosa et al(3). Similar Equations have also been invented for pressure controlled mode of ventilation(4)(5).

One of the limitations of the idea of mechanical power include the lack of normalization. Mechanical power threshold that may induce lung injury in a child may not be same as mechanical power threshold for an adult and among adults too, there may be variability in the sizes of ventilable lungs. Mechanical power thus needs normalization to predicted body weight or functional residual capacity to refine its prognostic ability.

Another problem with this index is that it includes the energy or power required to inflate the lung including the chest wall. As such, it may not truly represent the characteristics of lung in patient with higher contribution from the latter. Use of trans-pulmonary mechanical power may offset this problem. That would require us to use an esophageal probe to measure esophageal pressure as a surrogate for pleural pressure to calculate trans-pulmonary pressures and trans-pulmonary mechanical power.

 

Multiple human studies, mostly retrospective and secondary analysis of data from previous randomized controlled trials, have demonstrated that higher MP is associated with worse VILI and clinical outcomes including death in both ARDS and non-ARDS patients.

In our study we intend to look at the Mechanical power delivered to critically ill patients on mechanical ventilation and its association with clinical outcomes including mortality and analyze other associated clinical, laboratory and epidemiological variables.

Objectives

 

Primary Objective –

Descriptive analysis of Mechanical power being delivered to mechanically ventilated patients.

                              

Secondary Objectives –

1.      To assess the association between mechanical power and mortality within 30 days from the start of invasive mechanical ventilation.

2.      To assess association between mechanical power and ventilator free days till day 30.

To arrive at a threshold for mechanical power for predicting mortality.

Methodology

After screening for inclusion and exclusion criteria, data will be recorded as per the preformed case record form. Variables needed for Mechanical power calculation will be recorded soon after the patient is intubated and will be recorded every 6 hours until 96 hours or until the patient starts breathing spontaneously, whichever is earlier.

In our study, we’d limit ourselves to measuring the total mechanical power transferred to the respiratory system including the lungs as well as the chest wall assuming the contribution from the chest wall will be not so significant.

In addition to ventilatory variables and Mechanical power, other patient data including the Clinical and demographic details, APACHE and SOFA scores, hospital diagnosis, comorbidities and ICU diagnosis will also be collected. Patient would be followed up for 30 days from the day of start of invasive mechanical ventilation and outcomes including ventilator free days and/or mortality will be recorded.

Mechanical power will be calculated using Gattinoni’s simplified equation as well as Giosa’s surrogate equations.

Study Design – Prospective observational study

Study Place – Medical and surgical Intensive care units of Tata Memorial Centre, Parel, Mumbai

Sampling method – Sample of convenience

Statistical analysis –

Mean mechanical power delivered to each patient will be calculated.Patient characteristics and outcomes will be described as frequency with percentages or mean (SD) / Median (IQR) as appropriate. Quantitative data will be summarized using Mean (SD) if normally distributed. Median (IQR) will be reported if the data is non-normally distributed. The normality of quantitative data will be accessed using Kolmogorov-Smirnov’s test for normality.The association between Mechanical power and mortality and ventilator free days will be assessedusing multivariable logistic regression analysis. The threshold for Mechanical power will be determined through receiver operating characteristics analysis and Youden J index. A two tailed p value of <0.05 will be considered statistically significant.All statistical analysis will be performed using IBM SPSS v25. 
 
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