| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
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
|
|
|
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. |