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CTRI Number  CTRI/2024/02/063304 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Ultrasound assessment of respiratory muscles in ICU. 
Scientific Title of Study   Sonographic assessment of parasternal intercostal muscles and diaphragm during mechanical ventilation: A Prospective Observational 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  Nadia Rose 
Designation  Associate Professor 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of Anaesthesiology, Rajarajeswari medical college and Hospital,Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  09513454567  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nadia Rose 
Designation  Associate Professor 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of Anaesthesiology, Rajarajeswari medical college and Hospital,Bangalore


KARNATAKA
560074
India 
Phone  09513454567  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nadia Rose 
Designation  Associate Professor 
Affiliation  Rajarajeshwari medical college and hospital 
Address  Department of Anaesthesiology, Rajarajeswari medical college and Hospital,Bangalore


KARNATAKA
560074
India 
Phone  09513454567  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College and Hospital, Bangalore-560074  
 
Primary Sponsor  
Name  Nadia Rose 
Address  Department of Anaesthesiology, Rajarajeswari medical college and Hospital,Bangalore 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Nadia Rose  Rajarajeswari Medical college and hospital.  Department of Anaesthesiology, Rajarajeswari medical college and Hospital,Bangalore
Bangalore
KARNATAKA 
9513454567

dr.nadia.rose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajarajeswari medical college and hospital instituitional ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients expected to be mechanically ventilated for more than 48 hours in the age group 18-75 years. 
 
ExclusionCriteria 
Details  1) pregnancy
2)Pneumothorax
3)Tracheostomy
4)primary neuromuscular disease
5)Chest trauma, thoracic surgery,chest tube in situ
6) Dressing over measurement site.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assess changes in diaphragm and parasternal intercostal muscle thickness in patients undergoing mechanical ventilation.  Day 1 to extubation,death or discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate the role of diaphragm and parasternal intercostals muscle indices in predicting successful extubation or extubation failure during weaning from mechanical ventilation.  Day 1 to extubation 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   04/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

After institutional ethics committee approval, informed written consent will be taken from legally responsible relatives of patients satisfying the inclusion criteria.


Diaphragm measurement- 1) Thickness- High frequency 6-13 MHz linear probe in 8th-10Th intercoastal space between midaxillary line and anteroaxillary line perpendicular to chest wall, measured in semi recumbent position in 20-400. In B mode, the diaphragm will be seen as a 3-layered structure.The diaphragmatic pleura and peritoneal membrane will be parallel echoic lines, with hypoechoic muscle layer in between. Image will be frozen at the end of expiration and inspiration and the mean of three measurements will be taken. Thickening fraction will be calculated .

Parasternal intercostals muscle measurement: It will be measured using 10-15Mhz probe 3-5cmlaterally from sternum, sagittal plane between 2nd and 3rd rib.Image will be for measurement. It will be identified as a three-layered biconcave structure. It will be measured at craniocaudal midpoint between ribs. Thickening fraction will be calculated. Mean of three measurements will be taken for calculation. . For the sake of feasibility and convenience, ultrasound will be performed on the right parasternal intercostal muscle only.

Successful weaning will be defined as the ability of the patient to tolerate spontaneous breathing for at least 48 h.

Weaning failure will be defined as the requirement of non-invasive mechanical ventilation or re-intubation within 48 h of extubation.

 


 
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