| CTRI Number |
CTRI/2018/02/011713 [Registered on: 05/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Protocol Compliance |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Pilot study to assess PreSense system in improving turn-protocol compliance |
|
Scientific Title of Study
|
Pilot study on using a purpose built device (PreSense) to improve turn-protocol compliance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sridhar Nagaiyan |
| Designation |
Prinicipal Investigator |
| Affiliation |
Kauvery Hospitals |
| Address |
Kauvery Hospital, 199, Luz Church Rd, Kapali Thottam, Mylapore, Chennai, Tamil Nadu 600004.
Chennai
TAMIL NADU
600004
India |
| Phone |
|
| Fax |
|
| Email |
docsri@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renganathan B S |
| Designation |
Research Scholar |
| Affiliation |
IIT Madras |
| Address |
ESB319, Electrical Engineering, IIT Madras, Chennai – 600036.
Chennai
TAMIL NADU
600036
India |
| Phone |
|
| Fax |
|
| Email |
renganathan.b.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sridhar Nagaiyan |
| Designation |
Prinicipal Investigator |
| Affiliation |
Kauvery Hospitals |
| Address |
Kauvery Hospital, 199, Luz Church Rd, Kapali Thottam, Mylapore, Chennai, Tamil Nadu 600004.
Chennai
TAMIL NADU
600004
India |
| Phone |
|
| Fax |
|
| Email |
docsri@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Healthcare Technology Innovation Centre |
|
|
Primary Sponsor
|
| Name |
Healthcare Technology Innovation Centre |
| Address |
3E, 3rd Floor, IIT Madras Research Park, Kanagam Road, Taramani, Chennai, Tamil Nadu 600113 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sridhar Nagaiyan |
Kauvery Hospital, Chennai |
199, Luz Church Rd, Kapali Thottam, Mylapore, Chennai, Tamil Nadu- 600004.
Chennai
TAMIL NADU |
9840982101
docsri@hotmail.com |
| Dr K Senthil Kumar |
Kauvery Hospital, Tennur |
1, Keela Chathiram Road, Anna Nagar, Tennur, Tiruchirappalli, Tamil Nadu- 620017.
Tiruchirappalli
TAMIL NADU |
9843278833
senthilanaes@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kauvery Hospital Ethics Committee |
Approved |
| Kauvery Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pressure Ulcers, |
|
|
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 |
All adults admitted to Intensive Care Unit (ICU) who are considered at risk of acquiring
pressure ulcers can be enrolled in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients who cannot have the wearable device attached to their chest.
2. Patients who currently have implantable cardiovascular- defibrillator or pacemaker. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the current rate of compliance with prescribed turning protocols by using the system
proposed and to compare it with the compliance rate prior to introduction of the system proposed. |
On completion of pilot study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/02/2018 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an open arm trial assessing the safety and efficacy of PreSense designed for assisting caregivers in improving patient turn protocol compliance. It will be conducted in multiple centers in India. The primary outcome is to measure the current rate of compliance with prescribed turning protocols by using PreSense and to compare it with the compliance rate prior to the introduction of PreSense.
|