| CTRI Number |
CTRI/2024/03/064922 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
To make a new, easy to use tracheostomy tube suction device and to clinically validate its efficacy |
|
Scientific Title of Study
|
Device fabrication and clinical validation of a novel mechanical handheld suction device for tracheostomy tube cleaning: A pilot study |
| 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. Ritu Dudi |
| Designation |
Junior Resident Academic |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Otorhinolaryngology, 4th floor, teaching block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7011847639 |
| Fax |
|
| Email |
ritududi35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Sagar |
| Designation |
Additional professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Department of Otorhinolaryngology, 4th floor, teaching block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868078734 |
| Fax |
|
| Email |
sagardrprem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ritu Dudi |
| Designation |
Junior Resident Academic |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of otorhinolaryngology, 4th floor, teaching block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7011847639 |
| Fax |
|
| Email |
ritududi35@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intrtamural Research Grant by The Research section, AIIMS, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Research section, 1st floor, Academic block, AIIMS, New Delhi, 110029 |
| 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 Ritu Dudi |
AIIMS hospital |
Department of Otorhinolaryngology, D4 ward, Ward Block, AIIMS, New Delhi, 110029
New Delhi
DELHI |
7011847639
ritududi35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J399||Disease of upper respiratory tract, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Already existing suction devices |
Results will be compared with the already existing suction devices in terms of efficacy and ease of usage by trained medical professionals and patients care givers. |
| Intervention |
Tracheostomy tube suction device formulation and clinnical validation |
A tracheostomy tube suction device will be formulated and the efficacy will be tested on the patients of all age groups and genders according to the care givers and trained medical professionals. It will be tested on 10 individuals, at least 5 times for each individual for each size. |
|
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Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to participate in the study.
2. Any age or gender.
3. Tracheostomized for more than 48 hours.
|
|
| ExclusionCriteria |
| Details |
1. VERY SICK PATIENT ON MECHANICAL VENTOLATOR SUPPORT
2. UNCONSIOUS PATIENTS
3. NOT WILLING TO PARTICIPATE IN STUDY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A novel mechanical hand held simple suction device will be formulated and clinically tested |
A novel mechanical hand held simple suction device will be formulated and clinically tested at 5 different occasions in each patient. It will be done after 2 days of usage. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure the negative pressure created in already existing suction devices
2. to validate the clinical efficacy of the three sizes- small medium and large |
this is targeted to be done in 1.5 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
A novel mechanical hand held suction device will be fabricated and will be clinically validated. This study will take place in in-patient and out- patient department of Otorhinolaryngology in AIIMS, New Delhi in collaboration with NIFT, New Delhi. Fabrication of 10 number of prototypes of the suction device will be done according to negative pressure requirement for each size. There will be 3 size of the suction device. In clinical validation, each size suction device will be used in 10 patients at 50 different occasions. The efficacy will be graded by trained medical professionals and care givers of the patients.
|