| CTRI Number |
CTRI/2024/12/077891 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A Mobile Application called Trachcare to enhance and optimize tracheostomy care at home |
|
Scientific Title of Study
|
Trachcare A Mobile Application To Optimize Tracheostomy Care At Home Improving The Quality Of Life In Post Operative Tracheostomy Patients |
| 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 . Varsha Raghu |
| Designation |
Junior Resident |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Poonamallee Chennai
Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Poonamallee Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8754016295 |
| Fax |
|
| Email |
varsh1695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S ELANGOVAN |
| Designation |
Head of Department ( HOD), Department of Otorhinolaryngology |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee , Chennai
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9443413191 |
| Fax |
|
| Email |
subraelango@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. S . Elangovan |
| Designation |
Head of Department ( HOD), Department of Otorhinolaryngology |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee Chennai
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee Chennai
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9443413191 |
| Fax |
|
| Email |
subraelango@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee , Chennai , Tamil Nadu 602105 , India |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College and Hospital |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee Chennai |
| Type of Sponsor |
Other [SELF] |
|
|
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 Varsha Raghu |
Saveetha Medical College and Hospital |
304, Third floor, Department of ENT, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Poonamallee Chennai
Kancheepuram
TAMIL NADU |
8754016295
varsh1695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee ( SMCH-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J95-J95||Intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients > 18 years old who underwent tracheostomy un Saveetha Medical College and Hospital
Patients who are hemodynamically stable.
Those who have all cranial nerves intact.
Patients and attenders who are properly motivated |
|
| ExclusionCriteria |
| Details |
Poor pulmonary condition
Patients requiring ventilatory support |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The expected outcome of the study aims to demonstrate the effectiveness of integration of a
mobile application in post operative tracheostomy care at home , by enhancing patient
outcomes, reducing complications , promoting adherence to care protocols, facilitating
decannulation and alleviating caregiver burden. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Enhance Caregivers’ Understanding Of The Necessity And Implications Of
Tracheostomy Procedures, Thereby Improving Their Ability To Provide Effective
Care And Support To Patients .
To Mitigate The Risk Of Wound Site Infections And Pulmonary Complications
Associated With Tracheostomy By Providing Education On Proper Care Techniques,
Reminders For Hygeine Practices And Prompt Identification Of Potential
Complications.
To facilitate seamless communication between patients, caregivers, and healthcare
providers, enabling timely updates on patient progress, medication schedules, and
follow-up appointments. |
3 months |
|
|
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)
|
20/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction : Tracheostomy denotes the formation of an artificial airway in the trachea, is essential for ventilation but poses challenges for patients and caregivers in home care settings. This research aims to evaluate a mobile application’s impact on post-operative tracheostomy patients’ quality of life (QOL), home care management, and reduction of post-operative complications.Patients and caregivers face daunting challenges in managing tracheostomy care at home, including wound care, secretion management, and emergency preparedness. Recognizing these challenges, there’s a growing need for a holistic approach to tracheostomy care. The development of a mobile application aims to address these needs, supporting patients and caregivers in enhancing post-operative tracheostomy care. This study seeks to contribute to the evidence supporting mobile health technology integration in tracheostomy care, ultimately improving outcomes for patients and caregivers.
Aim and objectives of the research project: To assess the implication of an application in improving the post op tracheostomy care in patients, there by reducing the post operative complications. To Enhance Caregivers’ Understanding Of The Necessity And Implications Of Tracheostomy Procedures, Thereby Improving Their Ability To Provide Effective Care And Support To Patients . To Mitigate The Risk Of Wound Site Infections And Pulmonary Complications Associated With Tracheostomy By Providing Education On Proper Care Techniques, Reminders For Hygeine Practices And Prompt Identification Of Potential Complications. To facilitate seamless communication between patients, caregivers, and healthcare providers, enabling timely updates on patient progress, medication schedules, and follow-up appointments. |