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CTRI Number  CTRI/2025/03/083407 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 23/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Using Breathing Muscle Strength, Airway Pressure, and Lung Ultrasound to Predict Breathing Support Removal in Critically Ill Patients 
Scientific Title of Study   Combination of respiratory muscle strength, P0.1 and lung ultrasound score to predict weaning failure from mechanical ventilation in critically ill patients: A prospective observational study. 
Trial Acronym  CRPLUS trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jadav Sainath 
Designation  Senior resident 
Affiliation  Department of anaesthesiology and critical care AIIMS Raipur 
Address  ccu 2nd floor trauma building aiims raipur
anaesthesia department B Block aiims raipur
Raipur
CHHATTISGARH
492099
India 
Phone  8500028673  
Fax    
Email  jadav.sainath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chinmaya k panda 
Designation  associate professor 
Affiliation  Department of anaesthesia and critical care AIIMS Raipur 
Address  ccu 2nd floor trauma building aiims raipur
Anaesthesia department B block AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  8098007711  
Fax    
Email  chinmaya.panda06@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jadav Sainath 
Designation  Senior resident 
Affiliation  Department of Anaesthesia and critical care AIIMS Raipur 
Address  ccu 2nd floor trauma building aiims raipur
Anaesthesia department B Block AIIMS Raipur
Raipur
CHHATTISGARH
492099
India 
Phone  8500028673  
Fax    
Email  jadav.sainath@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology & Critical Care, AIIMS Raipur, Chhattisghar, 492099 
 
Primary Sponsor  
Name  Jadav Sainath 
Address  ccu 2nd floor trauma building aiims raipur, chhattisgarh, india 492099 
Type of Sponsor  Other [self] 
 
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 
Jadav Sainath  AIIMS Raipur  2nd Floor, Department of Anesthesiology and Critical Care, Trauma Building
Raipur
CHHATTISGARH 
8500028673

jadav.sainath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All india institute of medical sciences, raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z991||Dependence on respirator,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LUNG ULTRASOUND  Lung Ultrasound score, Respirstory Muscle Strength assessment by ultrasonography 30 mins after Spontaneous Breathing Trial 
Intervention  Mechanical Ventilation  P0.1 value assessment on ventilator 30 mins after Spontaneous Breathing Trial 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient eligible for SBT after 48 hrs of mechanical ventilation in CCU
Positive end-expiratory pressure less than or equal to 6 cm H2O
Partial Pressure of Arterial Oxygen more than or equal to 60 mmHg with fraction of inspired oxygen less than 0.45
GCS more than 13
Richmond Agitation Sedation Scale -1 to +1
Body Temperature less than 38 degree Celsius
Hematocrit level more than 21% or Hemoglobin level more than 7 g/dL
No or low doses of vasopressor support 
 
ExclusionCriteria 
Details  Patients with difficulty in obtaining ultrasound window
Mechanical Ventilation less than 48 hrs
History of Diaphragmatic Paralysis or Injury
Ascites
Thoracotomy
Pneumothorax
Pleural Effusion
Thoracic Trauma
History of Neuromuscular Disease
Pregnant women
Lactating or nursing mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the power of the Combination of respiratory muscle strength, P0.1 and
lung ultrasound score will predict weaning failure from mechanical ventilation in
critically ill patients. 
30 mins after Spontaneous Breathing Trial 
 
Secondary Outcome  
Outcome  TimePoints 
To assess Extubation failure  Upto 48 hours after extubation 
Requirement of noninvasive respiratory support after extubation  Upto 48 hours after extubation 
 
Target Sample Size   Total Sample Size="149"
Sample Size from India="149" 
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)   07/04/2025 
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)   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  

This thesis focuses on predicting weaning failure from mechanical ventilation in critically ill patients using a combination of respiratory muscle strength, airway occlusion pressure at 100 milliseconds (P0.1), and lung ultrasound score (LUS). Weaning from mechanical ventilation is a critical process in intensive care units (ICUs), where both premature and delayed extubation can lead to serious complications, including diaphragm dysfunction, ventilator-associated pneumonia, and airway trauma.

The study builds on prior research that has established the utility of different physiological markers in predicting weaning outcomes. The LUS, developed by Bouhemad et al., assesses lung aeration and has been shown to be an effective predictor of post-extubation distress. Similarly, diaphragmatic thickness and thickening fraction (DTF) have been linked to successful weaning. The P0.1 index, which measures central respiratory drive, has also been found to predict extubation success.

This observational study, conducted in a critical care unit, aims to integrate these parameters to improve the accuracy of weaning predictions. It involves assessing patients undergoing spontaneous breathing trials (SBT) through bedside ultrasonography, lung ultrasound, and respiratory drive monitoring. The study population includes critically ill patients eligible for weaning after at least 48 hours of mechanical ventilation, with specific inclusion and exclusion criteria to ensure valid results.

The methodology involves measuring LUS, diaphragmatic and intercostal muscle thickness, and P0.1 during the SBT, followed by statistical analysis to determine their predictive power. Ethical considerations include obtaining informed consent and ensuring patient safety.

The expected outcome is that the combined assessment of these physiological markers will provide a more reliable predictor for weaning success, reducing re-intubation rates and improving patient outcomes in the ICU.

 
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