| CTRI Number |
CTRI/2024/02/062241 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
02/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [nebulisation] |
| Study Design |
Other |
|
Public Title of Study
|
effectiveness of Hypertonic saline Nebulization on in managing acute exacerbation of COPD |
|
Scientific Title of Study
|
A Randomized Control Trial on effect of Halotherapy in improving airway clearance among patient with COPD admitted in selected tertiary care hospital of Western Maharashtra. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TULIKA DE BISWAS |
| Designation |
Clinical instructor |
| Affiliation |
College of Nursing, Armed Forces medical College & Hospital |
| Address |
Armed Forces Medical College, Pune
Solapur Road, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
09831782780 |
| Fax |
|
| Email |
tulikadebiswas@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
TULIKA DE BISWAS |
| Designation |
Clinical instructor |
| Affiliation |
College of Nursing, Armed Forces medical College & Hospital |
| Address |
Armed Forces Medical College, Pune
Solapur Road, Pune Cantt
Pune
MAHARASHTRA
411040
India |
| Phone |
09831782780 |
| Fax |
|
| Email |
tulikadebiswas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
TULIKA DE BISWAS |
| Designation |
Clinical instructor |
| Affiliation |
College of Nursing, Armed Forces medical College & Hospital |
| Address |
Armed Forces Medical College, Pune
Solapur Road Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
09831782780 |
| Fax |
|
| Email |
tulikadebiswas@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Manu Chopra |
| Address |
Armed Force Medical College Pune |
| 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 LT Col Manu Chopra |
Army Institute of Cardio thoracic Sciences |
Department of chest Medicine AICTS Pune
Pune
MAHARASHTRA |
9831782780
tulikadebiswas@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional Ethics committee, Armed Forces Medical College, Pune 411040 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hypertonic saline nebulization |
Hypertonic saline nebulization therapy for control group - nebulization with 3% NaCl 3 ml 6 hrly in a day for 7 days after routine broncodilator nebulisation) |
| Comparator Agent |
Routine broncodilator nebulisation |
Routine broncodilator nebulisation therapy for experimental group for 7 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients previously diagnosed with COPD and presently admitted with acute exacerbation having intermediate to high risk as per DECAF score |
|
| ExclusionCriteria |
| Details |
Patients with history of hospitalization in last 90 days.
Patients requiring invasive mechanical ventilation within 48 hours of hospitalization.
Patient with asthma COPD overlap and COPD bronchiectasis overlap.
• Non- consenting patients
• Patient allergic to Sodium Chloride.
• Patient geting other mucoactive substance other than standard treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in breathing pattern
Improvement in peak flow |
after 7 days therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
31/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
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
|
Hypertonic saline nebulization therapy Procedure: Random sampling of patients will be done. On admission mortality assessment will be done by DECAF score. Sample will be equally divided into 2 groups (Intermediate & High risk). Random sampling will be done to devide them in experimental and control grop.Experimental group will be administered 3% hypertonic saline nebulisation after routine broncodilator neblisation for 10 mins 6 hrly in a day for 07 days and control group will receive routine broncodilator neblisation treatment of exacerbation of COPD. Both groups will have control and experimental group. Groups will be assessed by modified borg scale, peak flow, duration of hospital stay, need of invasive ventilation & 30 day mortality with Spirometry, pulse oximetry, heart rate recording & respiratory rate recording to ensure the evidence of bronchospasm. Both the pre intervention and post intervention scores will be entered in coding sheet. |