| CTRI Number |
CTRI/2024/12/078786 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the effectiveness of Home based Tracheostomy Care Protocol on caregivers knowledge and skills of Children with Tracheostomy Tube |
|
Scientific Title of Study
|
An Experimental study to assess the effect of a Home based
Tracheostomy Tube Care protocol on the knowledge and skills of caregivers of children planned or discharged on tracheostomy tube in selected wards of APC and
ENT OPD PGIMER Chandigarh 2023 to 2024 |
| 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 Manisha Nagi |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing Education , PGIMER , Chandigarh |
| Address |
Department of National Institute of nursing education , PGIMER , Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592088036 |
| Fax |
|
| Email |
coolmanu6886@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Nagi |
| Designation |
Tutor |
| Affiliation |
National Institute of Nursing Education , PGIMER , Chandigarh |
| Address |
National Institute of Nursing Education , PGIMER , Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592088036 |
| Fax |
|
| Email |
coolmanu6886@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Nagi |
| Designation |
Tutor |
| Affiliation |
National Institute of nursing education , PGIMER , Chandigarh |
| Address |
National institute of Nursing Education , PGIMER , Sector 12 Chandigarh 160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9592088036 |
| Fax |
|
| Email |
coolmanu6886@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Room no. 4186 MINOR OT , ENT OPD and Advanced Paediatric Centre wards |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Manisha Nagi |
PGIMER CHANDIGARH |
ENT OPD , 4th floor, room number- 4086 ,NEW OPD and Advanced paediatric center ( 5th floor c block and 2nd floor PICU)
Chandigarh
CHANDIGARH |
9592088036
coolmanu6886@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee of NINE, PGIMER , CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G610||Guillain-Barre syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Home based Tracheostomy Tube Care protocol with videos |
Written content related to tracheostomy tube dressing and suctioning is created and validated from experts in nursing, paediatrics, and otolaryngology. Based
on the validated written content, their suggestions, modifications were made, and then videos
were subsequently produced accordingly on TT dressing
and suctioning, steps of hand washing. Duration of intervention is 1 month |
| Comparator Agent |
Routine care |
Routine care includes dressing and suctioning of the tracheostomy tube, as instructed by nursing professionals to caregivers of the children with tracheostomy tube upon discharge |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. children between the age group of 1 month to 12 years
2. caregivers between the age group of 18-60 years
3. Caregivers able to understand English , Hindi , Punjabi |
|
| ExclusionCriteria |
| Details |
1.unconscious patient
2. Those Caregivers who don’t have android phone and access to
internet |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To enhance knowledge and skills of caregivers of children discharged on tracheostomy tube |
First assessment will be taken after the implementation of the protocol (on
same day 3-4 hours after baseline assessment)) and second assessment will be taken after 5
to 7 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/02/2025 |
| 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)
|
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
|
Tracheostomy is a life saving procedure. Children experience higher morbidity and mortality due to young age and smaller airway. Caregivers often face challenges in providing long term care to these patients because of lack of necessary knowledge and skills. Considering this, the present study aims to evaluate the impact of a ’Home-Based Tracheostomy Tube Care’ protocol on the knowledge and skills of caregivers of children planned/discharged with a tracheostomy tube (TT). |