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CTRI Number  CTRI/2025/03/081652 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   identifying Extubation failure in ICU Patients Using Occlusion Airway Pressure (P0.1) Compared to Rapid Shallow Breathing Index (RSBI) 
Scientific Title of Study   Prediction of extubation outcome using Occlusion airway pressure (P 0.1) value over Rapid shallow breathing index (RSBI) in the intensive care unit  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prajna N S 
Designation  Postgraduate in Department of Respiratory Therapy 
Affiliation  KMC Mangalore 
Address  2nd floor ,Department of Respiratory Therapy, Kasturba Medical College centre for basic science , Bejai , Mangalore .

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9481766315  
Fax    
Email  prajnans9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr. Gautham Nayak  
Designation  Assistant Professor  
Affiliation  KMC Mangalore 
Address  2nd floor ,Department of Respiratory Therapy, Kasturba Medical College centre for basic science , Bejai , Mangalore .

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9113647963  
Fax    
Email  hamgautham1999@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prajna N S 
Designation  Postgraduate in Department of Respiratory Therapy 
Affiliation  KMC Mangalore 
Address  2nd floor ,Department of Respiratory Therapy, Kasturba Medical College centre for basic science , Bejai , Mangalore .

Dakshina Kannada
KARNATAKA
575004
India 
Phone  9481766315  
Fax    
Email  prajnans9@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Hospital, Attavar, Karnataka, India, Pincode-575002 and KMC Hospital, Dr B R Ambedkar Circle, Mangalore, Karnataka, India, Pincode-575001  
 
Primary Sponsor  
Name  Prajna N S 
Address  2nd floor , Department of Respiratory Therapy, Kasturba Medical College centre for basic science, Bejai, Mangalore, Karnataka, India, Pincode-575004 
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 
Dr Dattatray Prabhu  kasturba Medical College Hospital   MICU , 5th floor, Kasturba Medical College Hospital, Attavar, Mangalore.
Dakshina Kannada
KARNATAKA 		 8884955491

da.prabhu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College Mangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Age: 18 years and older.
2. Any gender.
3. Intubated patient on mechanical ventilator more than 24 hours.
4. Mechanically ventilated patients who are considered for weaning trials.
5. Planned extubation. 
 
ExclusionCriteria 
Details  1. Age less than 18 years.
2. Neurological Conditions: Conditions affecting respiratory drive or
consciousness (e.g., severe brain injury).
3. Discharge against medical advice patients
4. Self extubated patients
5. Tracheostomised patients.
6. Extubation for palliative care 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the predictive accuracy of P 0.1 values over RSBI scores during
weaning trials in determining extubation failure rates.
 		 After 30min,45min, 1hour of SBT Trail 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   11/03/2025 
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="0"
Months="10"
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 prospective observational study aims to compare the predictive accuracy of P0.1 over RSBI in determining successful weaning outcomes in mechanically ventilated ICU patients. 77 patients will be selected based on the inclusion and exclusion criteria using the consecutive sampling method. Eligible patients will undergo a spontaneous breathing trial (SBT), during which P0.1 and RSBI values will be recorded at 30, 45, and 60 minutes. The study aims to evaluate the predictive accuracy of Occlusion Airway Pressure (P0.1) compared to the Rapid Shallow Breathing Index (RSBI) in determining successful weaning outcomes and assessing reintubation incidence among extubated patients. The  outcome of the study is to evaluate the predictive accuracy of P0.1 values over RSBI scores during weaning trials in determining extubation failure rates. Continuous variables (e.g., age, APACHE II, and SOFA scores) will be expressed as mean ± standard deviation (SD) and categorical variables as counts and percentages. The predictive accuracy of P0.1 and RSBI will be assessed using Receiver Operating Characteristic (ROC) curve analysis, comparing the area under the curve (AUC) values to determine the superior predictor.

 
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