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CTRI Number  CTRI/2020/07/026427 [Registered on: 08/07/2020] Trial Registered Prospectively
Last Modified On: 16/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   The utility of intercostal respiratory muscle ultrasound scanning to predict which patients can be taken off the ventilator and its ability to identify patients who succeed in remaining off ventilatory support. 
Scientific Title of Study   ROLE OF PARASTERNAL INTERCOSTAL MUSCLE ULTRASOUND DURING WEANING FROM MECHANICAL VENTILATION AND PREDICTION OF EXTUBATION SUCCESS IN ICU – A PROSPECTIVE OBSERVATIONAL STUDY  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sundara Kannan A V 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anesthesia, Critical Care and Pain medicine, All India Institute of Medical Sciences, New Delhi.

South
DELHI
110029
India 
Phone  8968603573  
Fax    
Email  avsksundar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Puneet Khanna 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept o Anaesthesia, pain medicine and critica care, AIIMS, New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  k.punit@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Puneet Khanna 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Dept o Anaesthesia, pain medicine and critica care, AIIMS, New Delhi

West
DELHI
110029
India 
Phone    
Fax    
Email  k.punit@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 Puneet Khanna  All India Institute of Medical Sciences  Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
South
DELHI 		 9873106546

k.punit@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institue Ethics committee for post graduate research, All India Institute of Medical Sciences, New Delhi  Approved 
Institue Ethics committee for post graduate research, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age > 18 years
2. Duration of mechanical ventilation >48 hrs.
3. Eligible for a spontaneous breathing trial as decided by the intensivist, according to established guidelines.
 
 
ExclusionCriteria 
Details  1. Pregnancy
2. Patients with spinal cord injury at or above T12
3. Presence of significant arrhythmias
4. Patients with diaphragmatic paralysis/injury
5. Planned extubation into non-invasive ventilation / High flow nasal cannula (HFNC)
6. Surgical dressing significantly interfering with ultrasonography.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine whether the parasternal intercostal muscle thickening fraction measured by ultrasonography is useful in predicting weaning outcomes.  Parameters noted before and after a 30 minute spontaneous breathing trial. Outcome assessed after forty eight hours of planned extubation 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To determine the possibility of a composite index made up of echocardiographic parameters of systolic/diastolic cardiac function, ultrasound parameters of respiratory muscle function and LUS score, before and after SBT for predicting weaning outcomes  Parameters noted before a spontaneous breathing trial and after the spontaneous breathing trial, if successful. Outcome assessed after forty eight hours of planned extubation 
To observe the role of abdominal muscles in weaning process.  Parameters noted before a spontaneous breathing trial and after the spontaneous breathing trial, if successful. Outcome assessed after forty eight hours of planned extubation 
To assess various combinations of parameters and their ability to predict weaning outcomes.  Parameters noted before a spontaneous breathing trial and after the spontaneous breathing trial, if successful. Outcome assessed after forty eight hours of planned extubation. 
4. To study other variables during ICU stay associated with weaning outcomes.  Parameters noted before a spontaneous breathing trial and after the spontaneous breathing trial, if successful. Outcome assessed after forty eight hours of planned extubation 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2020 
Date of Study Completion (India) 03/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The research to predict whether patients in mechanical ventilation can be successfully liberated or not, active and still incomplete. The process of weaning and liberation from mechanical ventilation is physiologically complex and involves an interplay of lung parenchyma, respiratory muscle strength and cardiac reserve. Each of the factors has been shown to affect the weaning process. Respiratory muscle strength is usually assessed by diaphragm strength. But in some cases like abdominal surgery, diaphragm injury or repair this might not be possible.

We aim use to use the intercostal muscle function assessment as a tool to predict extubation sccess. The intercostal muscles will be assessed by their thickening during inspiration. If the diaphragm is weak or dysfunctional the intercostal muscles may overcompensate and may indicate weaning failure. They may also be overactive with lung parenchymal and cardiac dysfunction. The intercostal muscles will be assessed in the parasternal location and will be assessed before and after a spantaneous breathing trial

We also aim to develop a composite index made up of respiratory muscle strength, cardiac systolic/diastolic parameters and lung ultrasound score (to assess lung parenchyma), to predict weaning outcome.
 
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