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CTRI Number  CTRI/2024/09/073290 [Registered on: 03/09/2024] Trial Registered Prospectively
Last Modified On: 22/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   A Prospective observational study 
Study Design  Single Arm Study 
Public Title of Study   Correlation of continuous automatically measured mechanical power with manually calculated mechanical power in volume and pressure control modes  
Scientific Title of Study   Study to validate continuous automatic measurement of the mechanical power in mechanically ventilated children  
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 Farhan Shaikh 
Designation  Head department of pediatric intensive care unit, rainbow childrens hospital 
Affiliation  Rainbow childrens hospital 
Address  Pedaitric Intensive are unit-1, Floor 2, Rainbow childrens hospital, Road number 2, Banjara hills, Hyderabad, Telangana, 500034, India.

Hyderabad
TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  drfarhan@rainbowhospitals.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Farhan Shaikh 
Designation  Head department of pediatric intensive care unit, rainbow childrens hospital 
Affiliation  Rainbow childrens hospital 
Address  Pediatric intensive care unit -1, Floor 2, Rainbow childrens hospital, Road number 2, Banjara hills, Hyderabad, Telangana, 500034, India.


TELANGANA
500034
India 
Phone  9866007602  
Fax    
Email  drfarhan@rainbowhospitals.in  
 
Details of Contact Person
Public Query
 
Name  Dr Latha 
Designation  Research officer, rainbow childrens hospital 
Affiliation  Rainbow childrens hospital 
Address  Pediatric intensive care unit-1, Floor 2, Rainbow childrens hospital, Road number 2, Banjara hills, Hyderabad, Telangana, 500034, India.

Hyderabad
TELANGANA
500034
India 
Phone  9177100361  
Fax    
Email  lathasu@gmail.com  
 
Source of Monetary or Material Support  
Rainbow childrens hospital, road number 2, banjarahills, hyderabad,Telangana, India. 500034 
 
Primary Sponsor  
Name  Rainbow childrens Medicare Ltd  
Address  Rainbow childrens hospital, Road number 2, Banjara hills, Hyderabad, Telangana, 500034, India.  
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 Farhan Shaikh  Rainbow childrenss hospital  Pediatric Intensive care unit, 2nd floor, rainbow childrens hospital, Road number 2, bamjarahills, hyderabad
Hyderabad
TELANGANA 
9866007602

drfarhan@rainbowhospitals.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rainbow childrens hospital EC for biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  • All invasively ventilated children from 1 month of age until the age of 18-years shall be enrolled for the study irrespective of the reason for intubation and underlying lung condition 
 
ExclusionCriteria 
Details  • Children in prone position
• Children who are hemodynamically unstable for data collection.
• Children who are on High Frequency Oscillatory ventilation.
• Children with significant Patient Ventilator Asynchrony
• Children with air leaks, with chest Drains
• Children with raised Intra cranial pressure(ICP)
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To find the correlation of mechanical power continuously displayed on ventilator with simplified Gattinoni equation and Giosa equation in volume control mode and Becher in PC mode and to study the impact of change of tidal volume from 6ml/kg to 8ml/kg on change in mechanical power across different equations in volume control mode and becher equation in pressure control mode
 
With in 12 hours of intubation
 
 
Secondary Outcome  
Outcome  TimePoints 
To measure mechanical power at 6ml/kg and 8ml/kg tidal volume in volume control mode and pressure control mode   With in 12 hours of intubation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "147"
Final Enrollment numbers achieved (India)="147" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2024 
Date of Study Completion (India) 31/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Background: The primary aim of the study was to evaluate agreement between the automatically calculated mechanical power on the Mindray SV-600 ventilator (MPauto), and MP calculated using equations (MPcalc) across two tidal volumes (Vt) settings, ventilation modes and predefined age groups in invasively ventilated children.

Method: In this prospective observational physiology study, consecutive mechanically ventilated children from 1 month to 18 years of age were enrolled between August 2024 and May 2025 in a National Board of Exams-affiliated 30-bedded pediatric ICU. The data were collected within 24-hours of intubation, as soon as the patient was stable for data collection. Fifteen minutes before measurement, subjects were suctioned and circuit was cleared of water to prevent auto-triggering. Ventilator parameters were measured under static conditions. Flow and pressure values were obtained from the Mindray SV 600 ventilator, measured using differential pressure flow sensors and pressure sensors on the inspiratory and expiratory sides. Subjects were well sedated; If necessary, they were paralysed to ensure no spontaneous breathing during measurements. First the data was collected in Volume-Control Continuous mandatory ventilation (VC-CMV) at 6ml/kg Vt and then Vt increased to 8ml/kg and ventilated for 5 to 6 minutes to allow stabilisation and then data at 8ml/kg Vt was collected. After this, mode was changed to Pressure-control continuous mandatory ventilation (PC-CMV) mode and maintaining same Positive End Expiratory Pressure (PEEP) and Respiratory Rate (RR) and adjusting inspiratory time to accomodate the inspiratory flow and Peak Inspiratory Pressure (PIP)  was set to deliver 6ml/kg Vt. After 5 to 6 minutes of ventilation at this setting, data was collected. Now thw PIP was increased to deliver 8ml/kg Vt and after ventilating for 5 to 6 minutes at this Vt, data was now collected. In both PC-CMV and VC-CMV modes, inspiratory and expiratory holds were applied at each step to measure Pplat and PEEP, respectively. MPauto, calculated in real time by the Mindray SV-600 ventilator, was compared with equation-derived MP (MPcalc) using comprehensive and surrogate equations during continuous mandatory volume-control (VC-CMV) and pressure-control (PC-CMV) ventilation at Vt of 6 and 8 mL/kg body weight. Subgroup analyses considered age and pediatric ARDS (PARDS). In VC-CMV mode, MP was calculated with Gattinoni equation (MPVCcomprehensive) and Giosa surrogate equation (MPVCsurrogate). In PC-CMV mode, Van der Meijden comprehensive equation (MPPCcomprehensive) and Becher surrogate equation (MPPCsurrogate) were used. Bland-Altman analyses were used to evaluate the level of agreement.

Results: We included 147 children with median(IQR) age of 49 (16-92) months, of whom 34 had PARDS. MPauto showed strong agreement with MPcalc across ventilation modes and Vts settings. The agreement was highest in VC-CMV, with minimal bias (-0.12 to +0.011 Joules/min; ICC>/=0.95) and more than 88% of observations within CLoA. In PC-CMV, MPauto demonstrated systematic negative bias relative to MPcalc (Bias -1.23 to -0.62 Joules/min, ICC >/=0.92). These observations were also made among subjects with PARDS. Age affected the level of agreement between MPauto and MPcalc (slope: -0.008 to -0.005), particularly in PC-CMV mode (R2 = 0.226 to 0.27), where PARDS status modified this relationship only in PC-CMV mode (P<0.05)

Conclusion: MPauto by Mindray SV-600 demonstrated strong agreement with equation-derived MP during Volume-controlled ventilation across different age groups. However, MPauto showed a negative bias relative to equation-derived MP in pressure-controlled mode, particularly among younger children and those with PARDS

 
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