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CTRI Number  CTRI/2023/09/057314 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To take patient off breathing machine support (Ventilator)by examining breathing muscle (diaphragm) with ultrasound.  
Scientific Title of Study   Predictive value of diaphragmatic kinetics using tissue doppler imaging in weaning of patients from mechanical ventilation- An observational, prospective cohort 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  Priya Gole 
Designation  DrNB Resident 
Affiliation  Medanta - The Medicity, Gurugram 
Address  Medanta Institute of Critical Care and Anaesthesiology

Gurgaon
HARYANA
122001
India 
Phone  9325012811  
Fax    
Email  priya.priyagole@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepak Govil 
Designation  Vice Chairman- Critical Care 
Affiliation  Medanta - The Medicity, Gurugram 
Address  Medanta Institute of Critical Care and Anaesthesiology

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deepak Govil 
Designation  Vice Chairman- Critical Care 
Affiliation  Medanta - The Medicity, Gurugram 
Address  Medanta Institute of Critical Care and Anaesthesiology

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.com  
 
Source of Monetary or Material Support  
Medanta,The Medicity, Gurgaon 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
Dr Priya Gole  Medanta Institute of Critical Care and Anaesthesiology, Medanta - The Medicity, Gurugram  Medanta Institute of Critical Care and Anaesthesiology, Medanta - The Medicity, Sector 38, Gurugram,
Gurgaon
HARYANA 
9325012811

priya.priyagole@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee (MIEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J986||Disorders of diaphragm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  (1) Age ≥ 18 years
(2) On mechanical ventilation for more than 12 h
(3) Meeting all of the following criteria for the SBT:
a. FiO2<40%
b. Positive end-expiratory pressure ≤5 cmH2O
c. Respiratory rate≤30 breaths/min
d. Haemodynamic stability in the absence/ minimal vasopressors
 
 
ExclusionCriteria 
Details  1. Age <18 years
2. Neuromuscular diseases
3. Flail chest or multiple rib fracture
4. Morbid obesity (BMI> 40 kg/m2)
5. Inability to obtain a clear TDI signal of the right hemidiaphragm
6. Pregnant patient.
7. Tracheostomised patient
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation of diaphragmatic kinetics (Peak contraction velocity, peak relaxation velocity, velocity time integral, maximal relaxation rate) with weaning  Just before the Spontaneous Breathing Trial. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of reintubation within 48 hours of extubation.  Within 48 hours of extubation. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   20/09/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Weaning from mechanical ventilation is a challenging step during recovery from critical illness. Weaning failure or early reintubation are associated with increased morbidity and mortality, exposing patients to life-threatening complications. Weaning from mechanical ventilation involves change of positive pressure ventilation to negative pressure ventilation during spontaneous breathing trail (SBT) 

Diaphragm function is an important determinant of successful liberation from ventilation and recovery from critical illness. Invasive mechanical ventilation causes progressive decline in diaphragm bulk and strength in a phenomenon called ventilator induced diaphragm dysfunction [VIDD]. 
Our hypothesis is that diaphragmatic kinetic parameters differ between patients who have successful weaning as compared to patients with weaning failure and thus, diaphragmatic tissue doppler imaging (TDI) variables can be used as an adjuvant to spontaneous breathing trial (SBT).
Ultrasound is easily available in all the intensive care units. It is non-invasive, with no radiation effects, patient and intensivist friendly, can be repeated multiple times if necessary.Patient safety is not compromised and can be done at bed side. Patient need not be shifted out of ICU for any assessment. Patients who are  ≥ 18 years, on mechanical ventilation for more than 12 h and  meeting all of the following criteria for the SBT are included
On each TDI waveform following parameters will be identified and measured –Peak contraction velocity (PCV),Velocity–time integral (VTI), Peak relaxation velocity (PRV),Maximal relaxation rate (MRR)
Objective is to  compare diaphragmatic kinetics using tissue doppler imaging (peak contraction velocity, velocity time integral, peak relaxation velocity, maximal relaxation rate) in patients who had a successful weaning versus patients who had a weaning failure.
 
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