| CTRI Number |
CTRI/2024/08/071943 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Laryngo-tracheal airway narrowing |
|
Scientific Title of Study
|
To evaluate poor prognostic factors in laryngotracheal stenosis: An Ambispective 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 Arvind Kumar Kairo |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Otorhinolaryngology, AIIMS New Delhi, room 4057
New Delhi
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Kumar Kairo |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Otorhinolaryngology, AIIMS New Delhi, room 4057
New Delhi
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar Kairo |
| Designation |
Additional Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Otorhinolaryngology, AIIMS New Delhi, room 4057
New Delhi
DELHI
110029
India |
| Phone |
9868491991 |
| Fax |
|
| Email |
arvindkairo@yahoo.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, NEW DELHI, INDIA 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
AIIMS, Ansari Nagar East, 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 Yash Sikdar |
All India Institute of Medical Sciences |
AIIMS, New Delhi in the Department of Otorhinolaryngology & Head and Neck Surgery
New Delhi
DELHI |
9893005010
yashsikdar27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J386||Stenosis of larynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of all age group with LTS
2. Patient with clinical suspicion of laryngotracheal stenosis, who are symptomatic
3. Individuals giving consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patient who do not give consent to participate in the study
2. Patient unfit for surgery under general anaesthesia |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Decannulation
2. Failed Decannulation |
Decannulation (decannulation for duration of atleast 6 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Additional Surgery following Intervention |
Assessed at 6 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
13/08/2024 |
| 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="1"
Months="8"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The complexity
of the laryngotracheal framework, which coordinates the functions of
respiration, deglutition, and phonation, makes LTS, a difficult entity to
manage.
It is vital, therefore, that all patients of laryngeal narrowing be
managed by a multidisciplinary approach and a primary goal of establishing an
adequate laryngo-tracheal lumen with nasal breathing and enable eventual
decannulation. And there aren’t many studies which have quantified the outcome
in terms of decannulation on a long term follow up basis to look for
decannulation success/failure or re-stenosis, thereby guiding one in selection
of appropriate surgical intervention.
|