FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063487 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   How good are ventilatory ratio , P/F ratio and in combination in predicting outcome in acute lung injury  
Scientific Title of Study   The Predictive value of Ventilatory Ratio , PaO2/FiO2 ratio and their combination in the outcome of ARDS - A prospective observational study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep Bhatia  
Designation  Professor and head of the department  
Affiliation  AIIMS JODHPUR  
Address  3rd floor , emergency building , AICU,Department of anaesthesiology and critical care medicine ,AIIMS Jodhpur

Jodhpur
RAJASTHAN
342008
India 
Phone  919902492820  
Fax    
Email  pk_bhatia@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pradeep Bhatia  
Designation  Professor and head of the department  
Affiliation  AIIMS JODHPUR  
Address  3rd floor , emergency building , AICU,Department of anaesthesiology and critical care medicine ,AIIMS Jodhpur


RAJASTHAN
342008
India 
Phone  919902492820  
Fax    
Email  pk_bhatia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep Bhatia  
Designation  Professor and head of the department  
Affiliation  AIIMS JODHPUR  
Address  3rd floor , emergency building , AICU,Department of anaesthesiology and critical care medicine ,AIIMS Jodhpur


RAJASTHAN
342008
India 
Phone  919902492820  
Fax    
Email  pk_bhatia@yahoo.com  
 
Source of Monetary or Material Support  
Monetary source not required  
 
Primary Sponsor  
Name  AIIMS JODHPUR  
Address  1st phase, Basni , industrial area , Jodhpur  
Type of Sponsor  Other [Government medical college and research institute ] 
 
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 
Sachin   AIIMS JODHPUR   3rd floor , emergency building , AIIMS Jodhpur , Basni , phase 1 , industrial area , Jodhpur
Jodhpur
RAJASTHAN 
9902492820

22sksachin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee All India Institute of Medical Sciences Jodhpur   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  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients aged >18 years
Patients with ARDS by Berlin’s definition requiring intubation and mechanical ventilation 
 
ExclusionCriteria 
Details  The patient/relatives who refuse to give informed
consent
Age less than 18 years
Pregnant females
Moribund and Brain dead patients
Chest trauma
• Post thoracic surgery patients
• Pulmonary embolism
• Chronic respiratory failure
• Cardiac dysfunction 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ventilatory ratio , P/F ratio and their combination as a predictor of 28 day mortality in ARDS
 
28th day
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of ventilator days  28 days  
Length of stay in ICU  28days  
Effect of PEEP on VR  Multiple times in a day  
Effect of proning on VR  Whenever proned 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   11/03/2024 
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="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  

Acute respiratory distress syndrome (ARDS) is the acute onset of hypoxemia and bilateral pulmonary edema. ARDS is defined by the Berlin’s criteria.1 ARDS is a heterogenous disorder.

The PaO2/FIO2 ratio is a widely used bedside index of adequacy of oxygenation and to categorize disease severity in ARDS but it is a poor independent predictor of mortality in ARDS.2,3

Increased dead space ventilation has consistently been shown to be associated with increased mortality and disease progression in patients with acute respiratory distress syndrome (ARDS).4,5 Yet in day to day practice, dead space measurements are seldom performed. This is mainly due to problems associated with measuring dead space. The traditional method of calculating physiological dead space is cumbersome and requires a large chamber (Douglas Bag) for the collection of mixed expired gas.6 Volumetric Capnography is simple method but it is not integrated as standard in most commonly used ventilators and installation incurs additional expense. In addition, measured mixed expired PCO2 requires correction for compressed ventilator gas that contaminates the expired volume.7

Ventilatory ratio (VR) has been described as a bedside index that is easy to calculate and which monitors ventilatory efficiency8. VR is a product of measured expired minute ventilation(VE measured) and measured arterial PaCO2 (PaCO2 measured) normalized to a preset ventilator standard established from nomograms. VR is a unitless ratio.

Where, VE measured is the measured minute ventilation (ml/min)PaCO2 is the measured arterial partial pressure of carbon dioxide (mmHg)PBW- Predicted body weight 100- ideal minute ventilation (ml/min), 37.5- ideal PaC02 .

Ventilatory ratio correlates well with VD/VT in ARDS and higher values at baseline are associated with increased risk of adverse outcomes. VR is not affected by administration ofneuromuscular blocker.9

Most of the literature about VR is by retrospective studies and post hoc analysis. We plan to prospectively analyse VR, P/F ratio and their derived composite as a measure of severity and for bedside prognostication in ARDS.

 

Hypothesis: In this study we hypothesized that P/F ratio and VR combined are better predictor of mortality than either of them alone

Research questions: Is the combination of P/F ratio and VR, a better predictor of mortality than either of them alone in  ARDS 

Aims and Objectives: Aim of the study: To determine the predictive value of Ventilatory ratio, PaO2/Fio2 and their combination in outcome of ARDS


Detailed methodology: Patient will be recruited once admitted to ICU. The ventilator settings and various adjustments will left at the discretion of attending intensivist. Usually ARDSnet protocol is followed. Anthropometry (age, sex, weight, height and predicted body weight), respiratory variables (tidal volume, respiratory rate, minute ventilation, SpO2, PaCO2, P/F ratio, PEEP), MAP and APACHE II score will be noted. The goal of oxygenation is to target a peripheral blood oxygen saturation (SpO2) between 88% and 95% measured by pulse oximetry, or a partial pressure of oxygen (PaO2) of 55–80 mmHg measured by arterial blood gas analysis.

On admission arterial blood gas will be analysed and P/F ratio will be calculated. Within 30 minutes of ABG, ventilatory ratio will be calculated by measuring minute ventilation and measured PaCO2 and incorporating them into the formula i.e, 

 

              Where, VE measured is the measured minute ventilation (ml/min)

                             PaCO2 is the measured arterial partial pressure of carbon dioxide (mmHg)

                             PBW- Predicted body weight 

                            100- ideal minute ventilation (ml/min)

                            37.5- ideal PaCO2

Baseline VR will be taken after 1hour of stabilization of patient. Subsequently various measurements of VR and P/F ratio will be taken on days 1-4 and day 7 after 30 minutes ofchanges in ventilator settings/respiratory parameters/ any interventions during the ICU length of stay. Worst values of VR and P/F ratio will be taken for analysis out of the multiple measurements. All patients are to be followed up until 28 days after the admission.

Data analysis plan:

Continuous variables will be presented as Mean ± SD with 95% confidence interval. Quantitative variables will be compared by using student t-test if the data follows normal distribution. Otherwise non- parametric test (Mann Whitney U test) will be used. Chi-squared test for proportions will be used to test statistical differences between frequencies of categorical variables.The association between VR, P/F ratio and their combination with mortality will be assessed using univariate and multivariate regression.Kaplan-Meir survival curves will be plotted and log rank test will be used to compare survival curves.Two sided p-value of less than 0.05 will be considered significant.We will perform all analyses using Statistical Package for Social Sciences (SPSS, version 23.0 for windows)

 
Close