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CTRI Number  CTRI/2023/05/052990 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   comparison of the use of contactless blood pressure monitoring with established blood pressure monitoring methods 
Scientific Title of Study   Comparison of contactless continuous non-invasive blood pressure monitoring with invasive blood pressure monitoring: an observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prakash Kumar Dubey 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna

Patna
BIHAR
800014
India 
Phone    
Fax    
Email  pkdubey@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Kumar Dubey 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna


BIHAR
800014
India 
Phone    
Fax    
Email  pkdubey@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prakash Kumar Dubey 
Designation  Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna


BIHAR
800014
India 
Phone    
Fax    
Email  pkdubey@hotmail.com  
 
Source of Monetary or Material Support  
Dr. Prakash K Dubey 
 
Primary Sponsor  
Name  Dr. Prakash K Dubey 
Address  Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Patna 
Type of Sponsor  Other [Self] 
 
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 Prakash K Dubey  IGIMS, Patna  First Floor, near OT complex, Department of Anaesthesiology
Patna
BIHAR 		 9430511851

pkdubey@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,IGIMS Patna  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Adult (>18 years old) ICU patient who already has an intra-arterial blood pressure measurement in place.
2.Weight between 40kg-150kgs
3.Have been connected to ICU monitor for blood pressure measurements using both IBP and CBP
4.They/ legal representative are able and willing to provide written informed consent
 
 
ExclusionCriteria 
Details  1.Weight below 40 kgs and above 150 kgs
2.Currently pregnant
3.Have any condition that could interfere with the subjects ability to tolerate continuous monitoring with IBP or periodic monitoring with CBP
4.Exhibit injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the investigator, may prevent proper cuff application or functioning
5.Level of agitation or non-compliance too high to enroll in opinion of PI
6.Needs the use of equipments whose operation can interfere with Dozee’s signal
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Dozee contactless BP using the IBP as the gold standard for continuous BP monitoring  From time of admission in the ICU to 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the Dozee BP to cuff based CBP  From time of admission in the ICU to 72 hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/06/2023 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Plan for publishing. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Continuous monitoring of vital signs occurs in intensive care units (ICUs) to detect developing instability and identify the need for intervention. However, outside ICU settings in step-down or ward units, there is a lack of monitoring and patients continue to be at high risk of cardiorespiratory compromise, which has both acute and long-term consequences. As a result, a major healthcare focus is on utilizing these hemodynamic signals to predict when such risks will occur and to provide timely intervention to maintain cardiovascular function and organ perfusion in order to avoid secondary injury. To that end real-time, continuous physiologic measurements of these hemodynamic signals are critical. Dozee uses the concept of ballistocardiography, a non-invasive technique for measuring micro-body vibrations arising from cardiac contractions. It has been validated for measuring heart rate (HR), respiration rate (RR), movement, and sleep. Contact accessories like SpO2 have been integrated. Through data analysis, it was noted that there is a pattern consistent with systolic BP changes. The current product has shown some correlation to cuff-based BP monitors and also to the IBP. 
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