| CTRI Number |
CTRI/2020/02/023662 [Registered on: 28/02/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of diaphragmatic parameters using ultrasound for predicting weaning outcome in patients on mechanical ventilation in intensive care unit setting |
|
Scientific Title of Study
|
Ultrasonographic assessment of diaphragmatic parameters for predicting weaning outcome in patients on mechanical ventilation in intensive care unit setting |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Gupta |
| Designation |
Post graduate student |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia, Vardhman Mahavir medical college and Safdarjung hospital
South West
DELHI
110029
India |
| Phone |
9711537301 |
| Fax |
|
| Email |
Sakshigupta2705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Talwar |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia, Vardhman Mahavir medical college and Safdarjung hospital
South West
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
Drvandanatalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Talwar |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir medical college and Safdarjung hospital |
| Address |
Department of anaesthesia, Vardhman Mahavir medical college and Safdarjung hospital
South West
DELHI
110029
India |
| Phone |
9811352251 |
| Fax |
|
| Email |
Drvandanatalwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Critical Care, Vardhman Mahavir medical college and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital New Delhi |
| 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 Sakshi Gupta |
Vardhman Mahavir medical college and Safdarjung hospital |
ICU, new emergency building, Vardhman Mahavir medical college and Safdarjung hospital, New Delhi
South West
DELHI |
9711537301
Sakshigupta2705@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Readiness for weaning from mechanical ventilation as assessed by Recovery from the cause of respiratory failure, Stable haemodynamic status with no requirement for vasopressors, Fully conscious, Glasgow Coma Scale Less than or equal to 14, Fraction of inspired oxygen (Fio2) less than0.5,positive end expiration pressure
(PEEP) Less than or equal to 5cm H2O, respiratory rate less than 30, partial pressure of oxygen (PaO2)/FiO2 more than 200 |
|
| ExclusionCriteria |
| Details |
1. Pneumothorax, pleural effusion, collapse, fibrosis
2. History of neuromuscular disease, diaphragmatic palsy, thoracic surgery, any mass or mechanical factor in chest or abdomen
3.Tracheostomy tube in situ
4. Pregnancy, ascites, morbid obesity
5. Surgical dressings over the right lower rib cage
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of diaphragmatic excursion and diaphragmatic thickness fraction by ultrasonography predicting weaning outcome in patients on mechanical ventilation. |
Patient hemodynamically stable, ventilating on T-piece for 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| correlation between diaphragmatic dysfunction with reintubation |
within 48 hours of extubation |
| Better predictor of diaphragmatic excursion or diaphragmatic thickness fraction |
After extubation |
| compare diaphragmatic rapid shallow breathing index (RSBI) with clinical RSBI |
before extubation |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
02/03/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The proposed cohort study will be conducted in the Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung Hospital, In 50 patients of age >18years over a period of 18 months. The aim of this study is to ultrasonographically assess diaphragmatic parameters for predicting weaning outcome in patients on mechanical ventilation in the intensive care unit setting. It will assess the diagnostic accuracy of diaphragmatic excursion and diaphragmatic thickness fraction by ultrasonography to predict weaning outcome in patients on mechanical ventilation. |