| CTRI Number |
CTRI/2019/07/020398 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
26/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of foreign bodies in aerodigestive tract |
|
Scientific Title of Study
|
A study of foreign bodies in upper aerodigestive tract |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gavendra P Dave |
| Designation |
First year resident ENT |
| Affiliation |
Government Medical College, Bhavnagar. |
| Address |
Room no-501, PG-3 hostel, Sir T hospital campus, Bhavnagar.
Kachchh
GUJARAT
364001
India |
| Phone |
9099029283 |
| Fax |
|
| Email |
gavendradave@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil Jha |
| Designation |
Professor |
| Affiliation |
Government Medical College |
| Address |
ENT Department, Sir T Hospital, GMC, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9426909700 |
| Fax |
|
| Email |
drsushiljha2019@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin Chaudhari |
| Designation |
PG student |
| Affiliation |
Government Medical College |
| Address |
Room no-803, PG-3 hostel, Sir T hospital campus, Bhavnagar.
Bhavnagar
GUJARAT
364001
India |
| Phone |
|
| Fax |
|
| Email |
nitinfrds@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Otorhinolaryngology,Government Medical College, Sir T Hospital, Bhavnagar. |
|
|
Primary Sponsor
|
| Name |
Department of ENT |
| Address |
Department of Otorhinolaryngology, Government Medical College, Sir T Hospital, Bhavnagar. |
| 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 Gavendra P Dave |
Sir T Hospital, Bhavnagar |
Department of ENT, Sir T Hospital, Bhavnagar
Bhavnagar
GUJARAT |
9099029283
gavendradave@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB, GMC BHAVNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T17||Foreign body in respiratory tract, (2) ICD-10 Condition: T18||Foreign body in alimentary tract, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients having foreign bodies in upper aerodigestive tract |
|
| ExclusionCriteria |
| Details |
Subjects giving negative consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Age distribution
Sex distribution
Types of foreign bodies
Sites of foreign bodies
Outcome
Complications |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Age distribution
Sex distribution
Types of foreign bodies
Sites of foreign bodies
Outcome
Complications |
2 years |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/07/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Foreign bodies in the aerodigestive tract are common.
Their effects may varies from minimal disturbance of function to severe
morbidity or even sudden death. They enter the aerodigestive tract because of
haste during eating, alcoholic intoxication, ill-fitting dentures, mentally
challenged persons and children, Plummer Vinson syndrome, oesophageal
strictures and carcinoma, contamination of food with foreign bodies. Foreign
bodies are common in young children because of their inborn tendency to put
things in natural orifices. Common symptoms are pain, fever, hoarseness,
dysphagia, odynophagia, intractable cough, choking (cafe coronary), difficulty
in breathing, haemoptysis and hematemesis. Signs include point tenderness,
palpatory thud, audible slap, stridor, respiratory distress, pneumothorax and
surgical emphysema.
|