| CTRI Number |
CTRI/2024/04/065366 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of compressed sponge Nasal pack versus compressed sponge Nasal pack with breathable tube on Eustachian tube function and arterial blood gas- A clinical trial |
|
Scientific Title of Study
|
Effect of completely occlusive nasal pack versus nasal pack with airway on eustachian tube function and arterial blood gas- a randomised controlled trial |
| 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 Hithyshree. N |
| Designation |
Junior resident |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Sri Devaraj urs medical college
Kolar
KARNATAKA
563103
India |
| Phone |
9886143406 |
| Fax |
|
| Email |
drhithyshree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S M AZEEM MOHIYUDDIN |
| Designation |
Professor |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Sri Devaraj urs medical college
Kolar
KARNATAKA
563103
India |
| Phone |
9886143406 |
| Fax |
|
| Email |
hitu.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hithyshree N |
| Designation |
Post graduation student |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Room No. 21
Department of ENT
Sri Devaraj urs medical college
Kolar
KARNATAKA
563103
India |
| Phone |
9886143406 |
| Fax |
|
| Email |
drhithyshree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 21
Department of ENT
Sri Devaraj urs medical college
Tamaka, Kolar 563103 |
|
|
Primary Sponsor
|
| Name |
Dr Hithyshree N |
| Address |
Room no 21
Department of ENT
Sri Devaraj urs medical college
Tamaka, Kolar 563103 |
| Type of Sponsor |
Other [Post graduate resident] |
|
|
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 Hithyshree |
Sri Devaraj Urs medical college |
Room no.21, Department of ENT, Sri Devaraj urs medical college, Tamaka, Kolar 563103
Kolar
KARNATAKA |
9886143406
drhithyshree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R068||Other abnormalities of breathing, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
merocele nasal pack |
Completely occlusive nasal pack |
| Intervention |
Nasal pack with airway |
There will be a ventilation tube with the nasal pack |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged between 18- 60 years planned for nasal surgeries and patients with epistaxis requiring bilateral anterior nasal packs
|
|
| ExclusionCriteria |
| Details |
1. Patients with mucociliary disorders
2. Patients requiring posterior nasal pack
3. Patients who have received radiation to nasopharynx or the surrounding areas
4. Very obese patients with history of obstructive sleep apnea
5. Patients with impaired cardiac functions.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Middle ear aeration and pulmonary ventilation |
At baseline & Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oxygen saturation |
Post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
17/04/2024 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Nasal packs are usually used in case of epistaxis and after nasal surgeries to control bleeding and to support and stabilize the bony and cartilaginous structures. Due to packing, patients experience significant discomfort in the post-operative period. Bilateral nasal packing can lead to compromised Eustachian tube function. Eustachian tube patency is very important to maintain middle ear pressure and its dysfunction can lead to Eustachian tube catarrh, secretory otitis media. Nasal obstruction can lead to hypoxia, sleep apnea especially in patients with vulnerable cardiac function or poor lung capacity. Mouth breathing can also lead to imbalance in the acid- base due to disturbance in pulmonary ventilation. Some patients may experience fall in saturation when in deep sleep. In this study, the pulmonary side effects and alterations in Eustachian tube function associated with the use of nasal packs will be evaluated. The effect of totally occlusive nasal pack and nasal pack with airways on pulmonary and Eustachian tube function will be compared. |