| CTRI Number |
CTRI/2023/07/054806 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
28/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability of CT virtual bronchoscopy to prevent unnecessary intraoperative rigid bronchoscopy in cases of Tracheobronchial foreign bodies. |
|
Scientific Title of Study
|
Correlation between virtual bronchoscopy with intraoperative rigid bronchoscopy findings in Tracheobronchial foreign bodies. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran R B |
| Designation |
Associate Professor in Department of ENT, KIMS Hubballi. |
| Affiliation |
KIMS HUBBALLI, KARNATAKA |
| Address |
Room no 60, Department of ENT, OPD block, KIMS HUBBALLI, Karnataka 580021
Dharwad
KARNATAKA
580021
India |
| Phone |
|
| Fax |
|
| Email |
kiranbongale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran R B |
| Designation |
Associate Professor in Department of ENT, KIMS Hubballi. |
| Affiliation |
KIMS HUBBALLI, KARNATAKA |
| Address |
Room no 60,Department of ENT, OPD block,KIMS HUBBALLI, Karnataka 580021
Dharwad
KARNATAKA
580021
India |
| Phone |
|
| Fax |
|
| Email |
kiranbongale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran R B |
| Designation |
Associate Professor in Department of ENT, KIMS Hubballi. |
| Affiliation |
KIMS HUBBALLI, KARNATAKA |
| Address |
Room no 60, Department of ENT,OPD block, KIMS HUBBALLI, Karnataka, 580021
Dharwad
KARNATAKA
580021
India |
| Phone |
|
| Fax |
|
| Email |
kiranbongale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Emergency ward, Pediatric ward, Pediatric ICU ward of Karnataka Institute of medical sciences Hubballi |
|
|
Primary Sponsor
|
| Name |
KIMS Hubballi |
| Address |
Karnataka Institute of Medical sciences, Hubbali, Karnataka, 580021 |
| Type of Sponsor |
Government medical college |
|
|
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 Kalpana Daga |
Karnataka Institue of Medical Sciences |
Department of ENT, KIMS, Hubballi, Dharwad district,Karnataka,580021
Dharwad
KARNATAKA |
09815113678
kalpanadaga.fzk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T179||Foreign body in respiratory tract,part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
(1) A history suggestive of foreign body aspiration
(2) Clinical features of lower airway foreign body, such as sudden onset of coughing, difficulty in breathing, hemoptysis, pneumonia, wheezing and decreased air entry into the lungs. |
|
| ExclusionCriteria |
| Details |
1. Contraindications to rigid bronchoscopy
a)unstable neck
b)severely ankylosed cervical spine
c)temporomandibular joint pathology
d)unstable cardiovascular status likely to worsen during endoscopy unless there was clear evidence of life-threatening foreign body aspiration.
2. Metallic tracheobronchial foreign bodies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Corelate Virtual Bronchoscopy findings and Intraoperative Bronchoscopy findings. |
One and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the usefulness of Virtual Bronchoscopy in cases with no history & with history of foreign body aspiration. |
One & half years |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/07/2023 |
| 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="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
|
Foreign body aspiration remains an significant cause of morbidity and mortality in children in developing
countries. Foreign body aspiration may lead to serious complications
like severe airway obstruction and death, long-standing foreign bodies can cause tissue reaction, oedema and
secondary Infection. Tracheobronchial foreign bodies require rigid bronchoscopy removal, which has high
mortality rate up to 1.8%, Virtual bronchoscopy will avoid needless rigid bronchoscopy and its complications.
This study aims to corelate the findings of virtual bronchoscopy with actual rigid bronchoscopy in the case of
tracheobronchial foreign bodies. As there are less published studies on comparison and evaluation of the
diagnostic parameters and assessed the usefulness of virtual bronchoscopy and Intraoperative Bronchoscopy in
managing tracheobronchial foreign bodies |