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CTRI Number  CTRI/2024/01/061846 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 23/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluating the Diaphragm Parameters by Ultrasound to Predict Weaning from Mechanical Ventilation 
Scientific Title of Study   Sonographic Assessment of Diaphragmatic Indices for Predicting Weaning in Patients on Mechanical Ventilation 
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 Kirankumar C 
Designation  Senior Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anesthesia and Critical Care Medicine VMMC and Safdarjung Hospital

New Delhi
DELHI
110029
India 
Phone  7010403313  
Fax    
Email  kirankumar.c2009@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Poonam Gupta 
Designation  Professor and Consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anesthesiology and Critical Care VMMC and Safdarjung Hospital Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  9818623450  
Fax    
Email  p.gupta182@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poonam Gupta 
Designation  Senior Resident 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anesthesiology and Critical Care VMMC and Safdarjung Hospital Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  09818623450  
Fax    
Email  p.gupta182@gmail.com  
 
Source of Monetary or Material Support  
Vardhman Mahavir Medical College and Safdarjung Hospital 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Sadarjung Hospital 
Address  ansari nagar west, New Delhi 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kirankumar C  Vardhman Mahavir Medical College and Safdarjung Hospital  Department of Anesthesiology and Critical Care Vardhman Mahavir Medical College and Safdarjung Hospital Ansari Nagar East
New Delhi
DELHI 
7010403313

kirankumar.c2009@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1-Age > 18 years
2-On mechanical ventilator ≥48 hours
 
 
ExclusionCriteria 
Details  1-History of neuromuscular disease, diaphragmatic palsy, thoracic surgery, any mass or mechanical factor in chest or abdomen
2-Low Glasgow coma score
3-Pregnancy, ascites, morbid obesity
4-Increased intra-abdominal pressure.
5-Lung collapse and large pleural effusion
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess the accuracy of diaphragmatic indices (Diaphragm excursion, Time to peak amplification, and diaphragm thickness fraction) by ultrasonography to predict successful weaning in patients on mechanical ventilation.
2.To evaluate the best measured variables to predict successful weaning .
 
At the time, just before extubation of the patient from mechanical ventilator. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare diaphragmatic parameters with Rapid shallow breathing index (RSBI).
2.To assess the association between diaphragmatic indices & diaphragmatic dysfunction & reintubation
3.To assess the patients’ characteristics like age, sex, SOFA score, APACHE II score, type of mode of mechanical ventilation & comorbidities for diaphragm dysfunction and
4.To assess the duration on mechanical ventilation & ICU stay.
 
At the time, just before extubation of the patient from mechanical ventilator.
 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/02/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

A great number of critically ill patients in intensive care unit require invasive mechanical ventilation as a part of their care. Despite being life savior, liberation from ventilator is very challenging and time consuming. Untimely discontinuation of mechanical ventilation may lead to amplified cardiovascular and respiratory stress, CO2 retention and hypoxemia with up to 25% of patients requiring reinstitution of ventilator support. Unnecessary delays in weaning from mechanical ventilation can also be deleterious. Complications such as ventilator associated pneumonia and ventilator induced diaphragm atrophy can be seen even with short periods of mechanical ventilation thereby prolonging mechanical ventilation. 

Nevertheless, mechanical ventilation or the underlying ailment can lead to diaphragmatic dysfunction, a condition that may contribute to weaning failure. Extended      time on the ventilator greatly increases patient morbidity and mortality. Symptoms and signs of muscle disease in ICU patient are often difficult to evaluate because of concomitant confounding factors. Weaning is a continuous process, which starts with recognition of patient being ready to be weaned off from ventilator. Several parameters such as rapid shallow breathing index, vital capacity and maximum peak inspiratory pressure are being used routinely to extubate a patient from mechanical ventilator but the sensitivity, specificity, positive predictive value, and negative predictive values are highly variable. Moreover, these parameters do not assess the diaphragm dysfunction which is the major respiratory muscle and prime cause for the weaning failure. 

Conservative assessment of diaphragm function lacks  specific, noninvasive, time-saving, and easily performed bedside tools or requires patient cooperation. In recent times, the use of ultrasound has risen as a simple, noninvasive method of quantification of diaphragmatic excursion and contractile activity. Ultrasonography is a feasible, relatively inexpensive, radiation-free imaging modality which allows the visualization of muscle contractions; and has been shown to used successfully at bedside to evaluate diaphragm dysfunction, which is taken to be diaphragmatic excursion < 10mm and diaphragmatic thickness fraction <30%. It can distinguish between diaphragmatic paralysis, paradoxical upward movement, or immobility of the diaphragm. 

Hence, we aim to assess the diaphragmatic indices by ultrasound for predicting weaning outcome in patients on mechanical ventilation in the ICU setting.

 
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