| CTRI Number |
CTRI/2023/08/056197 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Lung And Diaphragm ultrasonography In Successfully Taking Out Patients Out Of Ventilator In ICU Weaning From Mechanical Ventilation In Icu Patients |
|
Scientific Title of Study
|
Lung And Diaphragm ultrasonography And Rapid Shallow Breathing Index As A Predictor For Successful Weaning From Mechanical Ventilation In Icu 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 Taniya Aggarwal |
| Designation |
Postgraduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
4th Floor BL Tanja Block Department Of Anaesthesia Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7838881743 |
| Fax |
|
| Email |
taniyaaggarwal95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kohli |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
4th Floor BL Tanja Block Department Of Anaesthesia Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9818073402 |
| Fax |
|
| Email |
dramitkohli@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kohli |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
4th Floor BL Tanja Block Department Of Anaesthesia Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9818073402 |
| Fax |
|
| Email |
dramitkohli@yahoo.com |
|
|
Source of Monetary or Material Support
|
| 3rd Floor BL Tanja Block Department of Anaesthesiology Maulana Azad Medical College JLN Marg Bahadurshah Zafar Marg Lok Nayak hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College And Associated Hospitals JLN Marg New Delhi 110002 |
| 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 Taniya Aggarwal |
Maulana Azad Medical College And Associated Hospitals |
Department Of Anaesthesiology BL Tanja Block Room No: 415 Maulana Azad Medical College Bahadurshah Zafar Marg JLN Marg New Delhi
Central
DELHI |
7838881743
taniyaaggarwal95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Maulana Azad Medical College And Associated Hospitals |
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 |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 to 65 years
2. Mechanical ventilation for minimum 48 hours an |
|
| ExclusionCriteria |
| Details |
1. Patients with history of neuromuscular disease
2. Patients with history suggestive of diaphragmatic dysfunction
3. Patients with chest tube in situ
4. Patients with pneumothorax & pneumomediastinum
5. Patients with chronic obstructive pulmonary disease
6. Pregnant Patients
7. Patients with known heart failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Diaphragmatic Thickening Fraction (DTF) as a predictor for successful weaning in ICU patients |
30 minutes from spontaneous breathing trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the Diaphragmatic Excursion (DE), Lung Ultrasound Score (LUS) & Rapid Shallow Breathing Index (RSBI) as a predictor for successful weaning in ICU patients |
Rapid Shallow Breathing Index (RSBI) at 5 & 30 minutes of spontaneous breathing trial
Diaphragmatic Excursion (DE) & Lung Ultrasound Score (LUS) at 30 minutes of spontaneous breathing trial
|
| Maximum expiratory pressure (MEP) & Maximum Inspiratory Pressure (MIP) to predict successful weaning |
5 minutes & 30 minutes from spontaneous breathing trial |
| The number of patients requiring Non-Invasive Ventilation (NIV) or reintubation within 24 hours of extubation |
Within 24 hours from extubation |
| Time to reintubation/non-invasive ventilation: Time interval between the point of extubation & the point of non-invasive ventilation/reintubation if done. |
Within 24 hours from extubation |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
14/08/2023 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This is a prospective observational study, predicting successful weaning in mechanically ventilated patients admitted in icu of Lok Nayak Hospital New Delhi who are undergoing spontaneous breathing trial by measuring diaphragm thickening fraction and diaphragm excursion and lung ultrasound score by doing diaphragm and lung ultrasonography respectively, rapid shallow breathing index, MEP and MIP at specified time of spontaneous breathing trial. Following this patient will be extubated and assessed for the success of weaning and the need for need of non-invasive ventilation or re intubation for 24 hours by doing arterial blood gas analysis at 1st and 6th hour post extubation. |