| CTRI Number |
CTRI/2024/02/063044 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE, RANDOMIZED |
| Study Design |
Other |
|
Public Title of Study
|
Effect of oxygen supplementation in COPD patient. |
|
Scientific Title of Study
|
Comparison of effect of helmet non invasive versus facemask non invasive ventilation in patient with acute exacerbation of COPD. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARIA IRSHAD |
| Designation |
Junior resident in anesthesia department |
| Affiliation |
Era Medical college and hospital Lucknow |
| Address |
Department of Anesthesiology Era Medical college and hospital
Lucknow Era Medical college and hospital sarfarazgunj lucknow UP
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7903657390 |
| Fax |
|
| Email |
sariairshad8485@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Piyush Shishir |
| Designation |
Associate Profressor, Anesthesiology |
| Affiliation |
Era Medical college and hospital Lucknow |
| Address |
Room no 8, first floor, Era Medical college and hospital Lucknow Era Medical college and
hospital sarfarzgunj Lucknow
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7007527560 |
| Fax |
|
| Email |
piyushshishir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mustahsin Malik |
| Designation |
HOD CCM Era Medical college and hospital Lucknow |
| Affiliation |
Era Medical college and hospital Lucknow |
| Address |
Room no 1,Second floor,Era Medical college and hospital Lucknow Era Medical college and
hospital sarfarzgunj Lucknow
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9871559131 |
| Fax |
|
| Email |
mustahsin.malik@gmail.com |
|
|
Source of Monetary or Material Support
|
| ERAs lucknow medical college, Lucknow |
|
|
Primary Sponsor
|
| Name |
Eras Lucknow Medical College |
| Address |
Sarfarzgunj, Lucknow, Uttar Pradesh. |
| Type of Sponsor |
Private 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 Saria Irshad |
Eras lucknow medical college |
Era Medical college and hospital Lucknow Era Medical college and
hospital sarfarzgunj Lucknow
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH |
8292226985
sariairshad8485@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
Patients 18 year or older with acute exacerbation of COPD |
|
| ExclusionCriteria |
| Details |
GCS more than 8, tracheostomy, elevated ICT, absent gag reflex, pregnant, Impending cardiopulmonary arrest. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will answer the question which modality of NIV (helmet versus facemask) is better in patients with acute exacerbation of COPD. |
28DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Low intubation rate expected |
28days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2024 |
| 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
|
COPD patient may required respiratory support and hospitalization due to an acute exacerbation of their disease. Non invasive ventilation represents the cornerstone treatment for the management of patient with AECOPD. NIV provides adequate ventilatory support and reduces the need for endotracheal intubation in patient with acute respiratory failure of various etiologies and in particular in patient with COPD. The major determinants of difficulty in patient ventilator interaction during pressure support ventilation. Aim comparison of effects of helmets non invasive ventilation and facemask non invasive ventilation in patients with acute exacerbation of COPD |