| CTRI Number |
CTRI/2024/08/072124 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
CROSS OVER |
| Study Design |
Other |
|
Public Title of Study
|
Compare two parameters,diaphragmatic rapid shallow breathing index and diaphragmatic thickness fraction,to predict successfully taking out from ventilator support in critically ill patient. |
|
Scientific Title of Study
|
A Comparative Study to evaluate
Diaphragmatic Rapid Shallow
Breathing Index and Diaphragmatic
Thickness Fraction for prediction of
successful weaning in critically ill
patients. |
| 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 Monica Chhikara |
| Designation |
Associate professor |
| Affiliation |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesiology
Pt B D Sharma
PGIMS Rohtak
ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
9468465746 |
| Fax |
|
| Email |
chhikara.monica@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahil Shiva |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesiology
Pt B D Sharma
PGIMS Rohtak
ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
7987418148 |
| Fax |
|
| Email |
sahilshiva54994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahil Shiva |
| Designation |
Junior resident |
| Affiliation |
Pt B D Sharma PGIMS |
| Address |
Department of Anaesthesiology
Pt B D Sharma
PGIMS Rohtak
ROHTAK
Rohtak
HARYANA
124001
India |
| Phone |
7987418148 |
| Fax |
|
| Email |
sahilshiva54994@gmail.com |
|
|
Source of Monetary or Material Support
|
| PT B D Sharma PGIMS Rohtak Haryana ,INDIA, pin code:124001 |
|
|
Primary Sponsor
|
| Name |
Pt B D Sharma PGIMS Rohtak |
| Address |
Department of Anaesthesiology
Pt B D Sharma PGIMS
Rohtak Haryana India
124001 |
| 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 Sahil Shiva |
PGIMS Rohtak Haryana |
Modular ICU,first floor,
Department of Anaesthesiology
New OT Complex
Rohtak
HARYANA |
7987418148
sahilshiva54994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
patient more than 18 years, with resolution of disease, adequate oxygenation,respiratory erate less than 30, stable haemodynamic,low analgesic requirement,effective cough,afebrile |
|
| ExclusionCriteria |
| Details |
patient less than 18 years,pregnancy, thoracostomy,pneumothorax,pneumomediastinum,flial chest,cervical spinal injury,nm blocker for 48 hours,newly detected paralysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
. To compare the correlation of Diaphragmatic Rapid Shallow Breathing Index and
Diaphragmatic Thickness Fraction for successful weaning. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict association of Lung Ultrasound Score (LUS) with successful weaning |
7 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
26/08/2024 |
| 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="0"
Months="11"
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
|
Many parameters are used to predict patients ability to breath spontaneously during weaning from ventilatory support like diaphragmatic rapid shallow breathing index, diaphragmatic thickness fraction, diaphragmatic excursion , lung ultrasound score but there is lack of data regarding which parameter is best among them for predicting successful weaning in such patients, so we are going to a comparative observational study to know which parameter better poredicts tge outcome of weaning in ventilator supported patients. |