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CTRI Number  CTRI/2022/10/046404 [Registered on: 12/10/2022] Trial Registered Prospectively
Last Modified On: 12/04/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Single Arm Study 
Public Title of Study   Role of centralized monitoring in general medicine wards  
Scientific Title of Study   A pilot observation study to assess the role of centralized monitoring in general medicine wards 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambuj Yadav 
Designation  Asst Professor, Dept of Medicine, KGMU 
Affiliation  King George’s Medical University 
Address  Doctors Chamber, Ground Floor, Gandhi Ward, Department of Medicine, KGMU, Shah Mina Rd Chowk, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9451631268  
Fax    
Email  dr.ambujyadav@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Kadambi  
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies  
Address  Turtle Shell Technologies City Centre, 40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru

Bangalore
KARNATAKA
560038
India 
Phone  9611197910  
Fax    
Email  pooja@dozee.io  
 
Details of Contact Person
Public Query
 
Name  Pooja Kadambi  
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies  
Address  Turtle Shell Technologies City Centre, 40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru

Bangalore
KARNATAKA
560038
India 
Phone  9611197910  
Fax    
Email  pooja@dozee.io  
 
Source of Monetary or Material Support  
Turtle Shell Technologies Private Limited City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038  
 
Primary Sponsor  
Name  Turtle Shell Technologies Private Limited  
Address  City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 
Type of Sponsor  Other [Medical Device] 
 
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 Ambuj Yadav  KGMU  Ward 1, 2, 5, 6, Ground and Second floor, Gandhi Ward, Department of Medicine, KGMU, Shah Mina Road, Lucknow Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH 
9451631268

dr.ambujyadav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University UP Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Adult (>18 years old) ward patient in one of the identified study wards
2. Weight between 40kg-150kgs
3. They/ legal representative are able and willing to provide written informed consent
 
 
ExclusionCriteria 
Details  1. Admitted for observation period of <24hours
2. Weight below 40kgs and above 150kgs
3. Have any condition that could interfere with the subjects ability to lie flat or stable on the bed (only for dozee arm) (severe bed sores, scoliosis, etc)
4. Needs the use of equipments whose operation can interfere with Dozee’s signal (only for dozee arm)
5. Patient not giving/unable to give consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in patient outcomes such as reduction in length of stay, timely ICU transfers and discharges, Benefits of central ward monitoring
Reduction in nurses’ time spent on monitoring, Cost effectiveness, Improvement in Healthcare provider satisfaction, Evaluation of technical performance of Dozee 
At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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)   18/10/2022 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

For hospitalized patients with unexpected clinical deterioration, delayed or suboptimal intervention is associated with increased morbidity and mortality. (1) The current nurse-to-patient ratio is 1:40, which is well over the recommended ratios (1:4 in a high-dependency unit and 1:2 in a step-down unit). (2) In India, continuous monitoring is not commonly used in the ward environment, despite a study suggesting that it would be possible and cost-effective in surgical wards, with the potential to improve patient outcomes when compared to intermittent monitoring. (3)

The patients benefit from frequent monitoring of vital signs and pulse oximetry, continuous electrocardiography monitoring, and higher nurse-to-patient ratios. (1) Among the growing possibilities to improve and simplify patient monitoring in hospital wards are contact-free sensors that enable early detection of clinical deterioration, which may avoid significant adverse events such as cardiac arrest. Secondary benefits may include cost saving from reduced high dependency/intensive care and improved patient health outcomes. Furthermore, a gap between ICU monitoring and home monitoring could be closed by upgrading monitoring strategies on hospital wards. (4)

Turtle Shell Technologies Pvt. Ltd. has developed a non-invasive continuous remote monitoring system Dozee. Salient features of Dozee include a) Rapid conversion of an existing ward bed into step-down ICU in under 10 minutes, b) Enabling continuous and remote monitoring of vital parameters (Heart Rate, Respiratory Rate, Oxygen Saturation and Blood Pressure) by healthcare providers within and outside the hospital), and c) Early Warning System to triage patients and alert health care providers about trends of deterioration seen in patients along with customizable alerts and user-friendly dashboard to monitor multiple beds from a single location.

This exploratory investigation will be conducted in four high-volume medicine wards of King George’s Medical University, Lucknow, to understand the effectiveness of the Dozee system. Among the 4 study wards, one male and one female wards will have Dozee deployed in them and compared to one male and one female control wards (without Dozee). This protocol is developed to assess and explore the improvements in patient outcomes, timely and unplanned ICU transfers, operational costs, patient out-of-pocket costs, healthcare provider time spent per patient specifically on vital monitoring, and health care providers satisfaction between the interventional device Dozee versus the standard of care.

1. Brown H, Terrence J, Vasquez P, Bates DW, Zimlichman E. Continuous monitoring in an inpatient medical-surgical unit: A controlled clinical trial. American Journal of Medicine. 2014 Mar;127(3):226–32. https://doi.org/10.1016/j.amjmed.2013.12.004 PMID: 24342543

2. Sharma S, Rani R. Nurse-to-patient ratio and nurse staffing norms for hospitals in India: A critical analysis of national benchmarks. Journal of Family Medicine and Primary Care. 2020;9(6):2631. https://doi.org/10.4103/jfmpc.jfmpc_248_20

3. Sun L, Joshi M, Khan SN, Ashrafian H, Darzi A. Clinical impact of multi-parameter continuous non-invasive monitoring in hospital wards: a systematic review and meta-analysis. J R Soc Med. 2020 Jun 1;113(6):217–24. https://doi.org/10.1177/0141076820925436 PMID: 32521195

4. Continuous Monitoring Beyond the ICU [Internet]. The impact of continuous versus intermittent vital signs monitoring in hospitals: A systematic review and narrative synthesis.

 
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