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CTRI Number  CTRI/2023/08/056669 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On: 20/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Relationship between work done by ventilator and number of days on mechanical ventilation in ICU patients with respiratory failure 
Scientific Title of Study   Correlation of Mechanical power to duration of mechanical ventilation in patients with respiratory failure-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  RajeshKannan Varadharajan 
Designation  Senior resident 
Affiliation  St.John s Medical college 
Address  Department of Critical care, St.John Medical College, John Nagar, Koramangala, Bengaluru, Karnataka-560034

Bangalore
KARNATAKA
560034
India 
Phone  8968189986  
Fax    
Email  phoenixrkan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Carol D silva 
Designation  Associate professor 
Affiliation  St.John medical college 
Address  Department of Critical care, St.John medical college, John nagar, Koramangala, Bengaluru, Karnataka-560034

Bangalore
KARNATAKA
560034
India 
Phone  9766397569  
Fax    
Email  carol.ds@stjohns.in  
 
Details of Contact Person
Public Query
 
Name  RajeshKannan Varadharajan 
Designation  Senior resident 
Affiliation  St.John s Medical college 
Address  DEepartment of critical care, St.John medical college, John nagar, Koramangala, Bengaluru, Karnataka-560034

Bangalore
KARNATAKA
560034
India 
Phone  8968189986  
Fax    
Email  phoenixrkan@gmail.com  
 
Source of Monetary or Material Support  
Department of Critical care, St.John Medical College, John nagar, Koramangala, Bengaluru, Karnataka-560034 
 
Primary Sponsor  
Name  RajeshKannan Varadharajan 
Address  Department of critical care, St.John Medical college, John Nagar, Koramangala, Bengaluru, Karnataka-560034 
Type of Sponsor  Private medical college 
 
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 
RajeshKannan Varadharajan  Medical ICU of St.John Medical College  Department of Critical Care, St.John Medical college, John Nagar, Koramangala, Bengaluru, Karnataka-560034
Bangalore
KARNATAKA 
8968189986

phoenixrkan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St Johns Medical college Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, (5) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (6) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (7) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (8) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (9) ICD-10 Condition: K00-K95||Diseases of the digestive system, (10) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
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 of age more than 18 years
Patients who require mechanical ventilation for atleast 48 hours for respiratory failure
Patients who have been sedated and paralysed at the time of evaluation in the first 24 hours 
 
ExclusionCriteria 
Details  Patients with obstructive airway diseases and in respiratory acidosis.
Patients requiring obligatory hyperventilation due to raised intracranial pressure of severe metabolic acidosis. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the mechanical power of ventilation on day 1 of ICU admission and determine itss correlation with the duration of mechanical ventilation  Day 1 of ICU admission 
 
Secondary Outcome  
Outcome  TimePoints 
1)To determine the correlation of mechanical power of ventilation on day 1 of ICU admission with the length of ICU stay/mortality.
2)Correlation of mechanical power with lung aeration score
3)Occurrence of Ventilator Induced Lung Injury-i)Barotrauma-Pneumothorax, Pneumomediastinum
ii)New onset worsening of oxygenation & radiological deterioration without an inciting cause. 
Till end of ICU stay/Death 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   30/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/08/2023 
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 Yet Recruiting 
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  

All patients admitted in St John’s Medical College Hospital ICU who are intubated and mechanically ventilated will be assessed for inclusion in the study within the first 24 hours of initiation of mechanical ventilation. For Consenting patients, Identification number and basic details - demographics will be entered in the Proforma. Comorbidities, reason for intubation, hemodynamic parameters will be noted.   

        All evaluations of ventilatory parameters and Ultrasound based evaluations shall be performed by principal investigator under supervision.

•      For patients who have been intubated, sedated and paralysed, on volume controlled ventilation the following parameters shall be noted down – respiratory rate (breaths/min) set, tidal volume (ml) set, minute volume set, PEEP (cm H2O) levels set and the inspiratory expiratory ratio set.

•      Peak pressure(PIP), plateau pressure (by applying inspiratory hold for 3-5 seconds), mean airway pressure, Total positive end expiratory pressure- PEEP ( by applying expiratory hold for 3 seconds) and hence auto PEEP, driving pressure ( plateau pressure – PEEP), (all in units of cm H2O) dynamic compliance (Vt/PIP-PEEP), static compliance (Vt/Plateau-PEEP), resistance  will also be noted down.

 

 

•      Mechanical power will be calculated according to the following equation as per the comprehensive equation for mechanical ventilation defined by gattinoni et al.

MP=0.098 * RR * Vt * [ PIP -0.5(Pplat-PEEP)]

·         Lung ultrasound will be done with a curved array transducer of 2-5MHz as per blue protocol and a composite lung aeration score will be calculated.

This score is computed in six regions per hemithorax: anterior, lateral, and posterior fields are identified by sternum, anterior, and posterior axillary lines; each field is divided into superior and inferior regions

Score

Lung findings

aeration

0

A-lines or ≤ 2 B-lines

normal

1

≥ 3 or more well spaced B-lines

Moderate loss

2

Coalescent B-lines

Severe loss

3

Tissue – like  pattern

Complete loss

 


 
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