| CTRI Number |
CTRI/2024/07/069810 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
This study aims to find the use of Ultrasonographic Diaphragmatic parameter in the weaning of mechanical ventilation from a patient |
|
Scientific Title of Study
|
To Evaluate Diaphragmatic Ultrasound Indices as Predictors of Successful Liberation From Mechanical Ventilation A Prospective Observation Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PANKAJ KUMAR |
| Designation |
Post Graduate Student |
| Affiliation |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dept of Critical Care Medicine.
4th Floor, Rm no 2, Shri Balaji Institute of Medical Science,Mowa,
Raipur
CHHATTISGARH
492001
India |
| Phone |
7979090084 |
| Fax |
|
| Email |
secrecy143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prafulla V Agnihotri |
| Designation |
Senior Consultant,HOD |
| Affiliation |
Shri Balaji Institute of Medical science |
| Address |
Dept of Critical Care Medicine
4th Floor rm no 2, Shri Balaji Institute of Medical College
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300206471 |
| Fax |
|
| Email |
prafullaagnihotri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prafulla V Agnihotri |
| Designation |
Senior Consultant,HOD |
| Affiliation |
Shri Balaji Institute of Medical science |
| Address |
Dept of Critical Care Medicine
4th Floor rm no 2, Shri Balaji Institute of Medical College
CHHATTISGARH
492001
India |
| Phone |
9300206471 |
| Fax |
|
| Email |
prafullaagnihotri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Balaji Institute of Medical Science,Mowa , Raipur Chhatisgarh PIncode 492001 |
|
|
Primary Sponsor
|
| Name |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
| Address |
Dept of Critical Care Medicine.
4th floor,Rm.no 2, Mowa,Raipur Chhatisgarh, 492001 |
| 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 Prafulla Agnihotri |
SHRI BALAJI INSTITUTE OF MEDICAL SCIENCE |
Dept of Critical Care Medicine, 4th floor,Rm.no 2,Mowa,Raipur
492001
Raipur
CHHATTISGARH |
9685699030
prafullaagnihotri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Balaji Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18 to 65 years at the time of randomization.
All patients on mechanical ventilation for more than 48 hours.
|
|
| ExclusionCriteria |
| Details |
Patients less than 18 years.
Diaphragmatic Paralysis.
A surgical dressing over the right lower rib cage that would preclude ultrasound examination
Patient with neuromuscular disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It includes any relationship between Diaphragmatic Ultrasonographic indices being measured before extubation and conservative extubation method |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of weaning failure and Diaphragmatic Indices during failure.
|
12 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Secrecy143@gmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 31-12-2035?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study includes patients on mechanical ventilation for more than 48 hrs. Patient diaphramatic indices with be noted using ultrasonographic machine 30 minutes after spontaneous breathing trial using conservative criteria. Data will be blinded from the the physician performing the liberaton from the mechanical ventilation. Statical analysis will be done to find out the relation between the successful weaning and the optimal diaphramatic indices at which it is achieved . This will further evaluate the prediction probability of the indices obtain in liberation from the mechanical ventilation successfully |