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CTRI Number  CTRI/2024/07/070583 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Prediction of ventilatory requirement in patients with severe lung disease by using ultrasound machine 
Scientific Title of Study   Ultrasonographic assessment of diaphragm to predict invasive ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kola Samatha Reddy 
Designation  1st year PG student Anaesthesia 
Affiliation  Shri b m patil medical college hospital andresearch centre 
Address  Anaesthesia Department Shri B M Patil Medical college hospital and Research center

Bijapur
KARNATAKA
586103
India 
Phone  9481121645  
Fax    
Email  reddysamathas84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Renuka holyachi 
Designation  Professor 
Affiliation  Shri b m patil medical college hospital andresearch center 
Address  Anaesthesia Department of Shri B M Patil Medical college hospital and Research center

Bijapur
KARNATAKA
586103
India 
Phone  9886492178  
Fax    
Email  renuka312@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kola Samatha Reddy 
Designation  1st year PG student Anaesthesia 
Affiliation  Shri b m patil medical college hospital andresearch centre 
Address  Anaesthesia Department Shri B M Patil Medical college hospital and Research center

Bijapur
KARNATAKA
586103
India 
Phone  9481121645  
Fax    
Email  reddysamathas84@gmail.com  
 
Source of Monetary or Material Support  
Shri B M Patil Medical college hospital and Research center, Bijapur district, karnataka, India, Pin-586103 
 
Primary Sponsor  
Name  Anaesthesia Department Shri B M Patil Medical college hospital and Research center 
Address  Shri B M Patil Medical college hospital and Research center Vijaypura-586103 Karnataka, India  
Type of Sponsor  Private 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 Kola Samatha Reddy  Shri B M Patil Medical College Hospital and Research Centre  Intensive care unit 3rd floor main building Shri B M Patil Medical college hospital and Research centre
Bijapur
KARNATAKA 		 9481121645

reddysamathas84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, BLDE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of either sex admitted to the intensive care unit with acute exacerbation of chronic obstructive pulmonary disease  
 
ExclusionCriteria 
Details  1.Contraindications of Non-invasive ventilation (unconscious uncooperative patients,shock,severe hemodynamic instability)
2.Neuromuscular disease
3.Chest wall deformities
4.Diaphragmatic palsy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The value of Diaphragmatic impairment to predict need for invasive mechanical ventilation after NIV failure  On admission, before starting NIV and after starting NIV

 
 
Secondary Outcome  
Outcome  TimePoints 
Impact of Diaphragmatic impairment.  1. During Mechanical ventilatory days
2. During total duration of ICU stay.
3. 28 day mortality. 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   25/07/2024 
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 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   COPD is the third leading cause of death worldwide. In case of respiratory failure, ventilatory support is necessary either in the form of NIV or IMV through endotracheal tube. Early use of NIV in patients with acute COPD is beneficial. The decision to institute IMV should be based on clinical judgement that integrates many clinical variables.
Ultrasonography is a non-invasive tool for quantification of diaphragmatic contractility through Diaphragmatic thickness or Diaphragmatic thickness fraction or diaphragmatic impairment. This makes USG assessment a reasonable tool during management plan.
This is a prospective observational study, which is going to happen over a period of 1 year.
The study sample was calculated using statistical package for the social sciences (version 20).
This study helps in assessing the ability of USG in predicting the requirement of IMV after NIV and also the impact of diaphragmatic impairment during ICU stay, MV days, and 28-day mortality.


 
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