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CTRI Number  CTRI/2024/04/066209 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Usage of Ultrasound to measure Chest muscle thickness for predicting successful weaning in patients on Mechanical ventilation in the Intensive care unit 
Scientific Title of Study   Ultrasonographic assessment of Intercostal muscle thickness for predicting weaning outcome in patients on Mechanical ventilation in the Intensive care unit. 
Trial Acronym  Prospective Observational Cohort study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Shadha Hind K K 
Designation  Post graduate student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital  
Address  Department of Anaesthesia and Critical Care, Ground floor, Main OT complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  8281768946  
Fax    
Email  shadhahind97@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  ICU-2,First floor, New Emergency block, Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi

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  ICU-2,First floor, New Emergency block, Department of Anaesthesia and Critical Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9811352251  
Fax    
Email  drvandanatalwar@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Critical Care, Ground floor, Main OT complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 
 
Primary Sponsor  
Name  VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL 
Address  Department of Anaesthesia and Critical Care, Ground floor, Main OT complex, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi 
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 
DR Shadha Hind K K  Vardhman Mahavir Medical College and Safdarjung Hospital   Room no-102, Intensive care unit, Department of Anaesthesia, Vardhman Mahavir Medical College and Safdarjung Hospital
South West
DELHI 		 8281768946

shadhahind97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government of India, Ministry of Health and Family Welfare, Vardhman Mahavir Medical college and Safdarjung Hospital, New Delhi, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  On mechanical ventilation for a minimum period of 24 hours with readiness of weaning as assessed by:
1)recovery from the cause of respiratory failure
2)stable hemodynamic status with no requirement for vasopressors
3)fully conscious with GCS more than or equal to 14
4)Fraction of inspired oxygen(FiO2)less then 0.5,Positive end expiratory pressure(PEEP)less than or equal to 5cm H20,Respiratory rate less than 30,Partial pressure of oxygen(Pao2)/Fraction of inspired oxygen(FiO2) more than 200 
 
ExclusionCriteria 
Details  1.Pneumothorax, pleural effusion, collapse, fibrosis
2.Rib fracture, thoracic surgery, thoracotomy
3.History of neuromuscular disease, diaphragmatic palsy, mechanical factor or surgical dressing over the chest.
4.Tracheostomy tube in situ
5.Pregnancy, ascites, morbid obesity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the sensitivity and specificity of ultrasonographic guided parasternal intercostal muscle thickness fraction (PICTF%) for predicting weaning outcome in patients on mechanical
ventilation in the intensive care unit.
 		 After 10 mins of Starting Spontaneous breathing trail (SBT)for weaning the patient from mechanical ventilation
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the predictive values of diaphragmatic thickness fraction (DTF) and parasternal intercostal muscle thickness fraction (PICTF) on ultrasonography for predicting weaning outcome in patients on mechanical ventilation in the intensive care unit.   After 10 mins of Starting Spontaneous breathing trail (SBT)for weaning the patient from mechanical ventilation
 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   29/04/2024 
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)   Other (Terminated) 
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   Mechanical ventilation is a lifesaving tool for critically ill patients admitted to the ICU. Weaning from invasive mechanical ventilation is as important as putting the patient on a ventilator, and this process lasts for approximately 42% of the total time a patient spends on mechanical ventilation. While prolonged duration of mechanical ventilation can lead to diaphragm dysfunction, ventilator-associated pneumonia (VAP) and airway trauma, early unplanned extubation may lead to complications such as aspiration, respiratory distress and hypoxia. Therefore, determining the optimal time and mode of weaning is a very important factor for patient outcome. There has been a growing interest in parasternal intercostal muscle ultrasound as a predictor of weaning. The intercostal muscles are a two layered structure that span each of the intercostal spaces. The “parasternal intercostal muscles” lie ventrally between the sternum and the chondrocostal junctions, where the internal intercostal muscles are replaced by a fibrous aponeurosis. These muscles are active only during the inspiratory phase of the breathing cycle and interact together with the diaphragm and other extradiaphramatic inspiratory muscles. The parasternal intercostal muscles are crucial for respiration, whenever there is an increase in ventilatory demand due to hypoxemia, carbon dioxide retention, high fever or shock. Thickening of parasternal intercostal muscle occurs in the presence of diaphragm dysfunction, and measurement of this parameter may contribute to the assessment of patient respiratory reserve capacity. The activation intensity of the parasternal intercostal muscle indicates a balance between the patient’s ventilatory demand and respiratory reserve. In such cases, the parasternal intercostal muscle thickness fraction (PICTF %) will be increased, which in-turn provides information on low vs high respiratory effort and helps in estimating the success of weaning. PICTF % can be calculated as [peak inspiratory thickness-end expiratory thickness]÷end expiratory thickness) *100.The primary aim of our study is ultrasonographic assessment of parasternal intercostal muscle thickness fraction (PICTF%) for predicting weaning outcome in patients on mechanical ventilation in the ICU. The study also aims to compare the predictive values of diaphragmatic thickness fraction (DTF) and parasternal intercostal muscle thickness fraction (PICTF) for weaning success. The study will be conducted on 75 patients admitted to the ICU, above 18 years of age, after taking informed consent from patient/relatives.
1.Demographic parameters such as name, age, sex, MRD no, height, weight, BMI will be noted
2.Lab parameters including Complete blood count, Renal Function Test (KFT), Liver Function Test (LFT), serum electrolytes and serum glucose at inclusion.
3.Sequential Organ Failure Assessment (SOFA), Acute Physiology and Chronic Health Evaluation (APACHE II) score at the time of admission to ICU
4.Intake of any drugs affecting respiratory muscle function such as neuromuscular blockers (NMB), steroids, aminoglycosides (AG), organophosphates (OP).
5.Physiological parameters including Heart Rate (HR), Mean Arterial Pressure (MAP),Respiratory rate (RR), SpO2 at inclusion and during SBT will be charted.
6.ABG - PH, PaCO2, PaO2, HCO3, Lactate before starting SBT and after 120 mins of  SBT to be assessed.
Patients’ readiness to wean from mechanical ventilation will be assessed by clinical judgement of ICU physician. Patient will be given SBT by putting the ventilator on PSV (Pressure Support Ventilation) mode of mechanical ventilation (MV) (0-PSV, PEEP-5cm H2O setting). Patient will be monitored for Heart rate, Noninvasive blood pressure (NIBP),Respiratory rate, Tidal volume, RSBI(Rapid shallow breathing index (RSBI) is calculated by dividing the respiratory rate (RR) by the tidal volume in litres), SpO2,Signs of respiratory distress- nasal flaring, sweating, agitation, Use of accessory muscle, ABG analysis- PaO2, PaCO2, PaO2/FiO2,Maximum Inspiratory Pressure, Maximum Expiratory Pressure, Parasternal intercostal muscle thickness fraction (PICTF%) – after 10 mins of SBT, Diaphragmatic parameters - Diaphragmatic thickness fraction - after 10 mins of SBT
*Parasternal intercostal muscle thickness fraction (PICTF%)-
Second right parasternal intercostal muscle will be assessed with a10- to 15-MHz linear array transducer which will be placed at the level of the second right intercostal space, approximately 6 to 8 cm lateral to the edge of sternum, perpendicular to the anterior surface of the thorax in the longitudinal scan, with a window visualizing the second and third ribs. The second right parasternal inter-costal muscle will be identified as a three-layered biconcave structure, with a medial portion showing muscle echotexture and two linear hyperechoic membranes running respectively from the anterior and posterior aspects of the adjoining ribs. The ultrasound beam will be directed at the midsection of the muscle perpendicularly, where it is the thinnest at end-expiration using M mode. At the peak of inspiration and end of expiration, the thickness of the parasternal intercostal muscle will be measured between the inner and outermost hyperechoic layer of muscle fascial borders using frozen images. PICTF% will be measured as “[peak thickness at inspiration(a) − end-expiratory thickness(b)] divided by end expiratory thickness] × 100”.
All measurements will be repeated on at least three separate breaths and their average will be reported.
*Diaphragm thickness fraction (DTF)-
DTF will be measured using M mode with a 7–10 MHz linear probe. The right hemidiaphragm will be visualized in the zone of apposition, on the midaxillary line between the 8th and 10th intercostal spaces. It will be recorded on M‐mode sonography in real time. During M‐mode imaging, the normally functioning diaphragm is represented as an echogenic line that moves freely during inspiration and expiration. Thickness will be measured by placing callipers on reflective lines at the end of inspiration and expiration. 
DTF will calculated by formula: TI- TE ×100.

                                       TE

When the SBT is successful after 120 mins, planned extubation will be performed on the basis of clinical assessment. All the patients will be followed up to 48 hrs for respiratory distress, and any requirement for non-invasive or invasive mode of mechanical ventilation. Incidence of VAP (Ventilator associated pneumonia) or any other complications, ICU mortality, need for tracheostomy and duration of ICU stay and duration of mechanical ventilation will be followed up. 

 

 
 
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