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CTRI Number  CTRI/2025/04/085216 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 16/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   Study to evaluate the use of ultrasound for assessing how much the breathing muscle called diaphragm thickens to help predict ventilation failure in a patient on tight fitting mask called noninvasive mask.  
Scientific Title of Study   Evaluation of diaphragmatic thickening fraction for prediction of noninvasive ventilation failure – 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  Satya Kumar Moharana 
Designation  Senior Resident 
Affiliation  St Johns Medical College 
Address  Department of Critical Care Medicine, St Johns Medical College, John Nagar, Koramangala, Bengaluru
John Nagar, Koramangala, Bengaluru, Karnataka, Pin 560034
Bangalore
KARNATAKA
560034
India 
Phone  9082134097  
Fax    
Email  satyakm90@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dipali Anand Taggarsi 
Designation  Assistant Professor 
Affiliation  St Johns Medical College 
Address  453, 13th Main, 18th cross, M.C. Layout, Vijaynagar, Bangalore
John Nagar, Koramangala, Bengaluru, Karnataka, Pin 560034
Bangalore
KARNATAKA
560040
India 
Phone  9902586487  
Fax    
Email  dipali.tagg@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dipali Anand Taggarsi 
Designation  Assistant Professor 
Affiliation  St Johns Medical College 
Address  453, 13th Main, 18th cross, M.C. Layout, Vijaynagar, Bangalore
John Nagar, Koramangala, Bengaluru, Karnataka, Pin 560034
Bangalore
KARNATAKA
560040
India 
Phone  9902586487  
Fax    
Email  dipali.tagg@gmail.com  
 
Source of Monetary or Material Support  
St Johns Medical College, Johns Nagar, Koramangala, Bengaluru, Karnataka, India, Pin - 560034 
 
Primary Sponsor  
Name  Satya Kumar Moharana 
Address  St Johns Medical college, John Nagar, Koramangala, Bengaluru, Karnataka, India, Pin - 560034  
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 Satya Kumar Moharana  St Johns Medical College  Department of Critical Care Medicine, St Johns Medical College, John Nagar, Koramangala, Bengaluru, Karnataka, Pin 560034
Bangalore
KARNATAKA 
09082134097

satyakm90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC St Johns Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J960||Acute respiratory failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Assessment of diaphragmatic thickness fraction using ultrasound for predicting NIV failure   Ultrasound assessment of diaphragmatic thickening fraction will be done within ½ hour of NIV initiation, 2 hours after initiation, 12 hours, 24 hours, 36 hours, 48 hours while the patient is on NIV. Readings will be measured till maximum of 48 hours. The patient will be followed up till he/she is discharged from the ICU. Diaphragmatic thickening fraction will be measured bed side by ultrasound with the help of 7 to 12 MHz linear probe using B mode. Patient position will be semi-reclined with average inclination of 45 degrees. Ultrasound will be positioned between 7th – 8th rib or 8th- 9th rib in the midaxillary and posterior axillary lines to acquire the best view of the zone of apposition. Zone of apposition is vertical area of the diaphragm that begins at the insertion point on the inside of lower ribs. Diaphragm is seen as three-layered structure with one non echogenic layer surrounded by 2 echogenic layers the parietal serosa and peritoneal serosa. Diaphragm Thickening fraction will be calculated with the formula (thickness at end-inspiration – Thickness at end-expiration)/Thickness at end expiration × 100. The point of assessment of the diaphragm will be marked to ensure accuracy of readings. 3 measurements will be taken and the average value will be taken for analysis. Diaphragm assessment will be done by trained critical care physicians. 3 different evaluators performing ultrasound assessments in our study. We will measure inter class correlation coefficient (ICC) and Bland - Altman analysis will be done to assess inter and intra-observer variability and validate the findings of the three evaluators. HACOR Scoring will be calculated based on 5 parameters Heart rate, Acidosis, Consciousness, Oxygenation, Respiratory rate with HACOR score 5 being considered as high risk of NIV failure. Failure of NIV will be documented if / when the patient is intubated. NIV Success will be defined as an absence of NIV requirement for 12 hours. The decision to intubate will be made by the treating physician, who will be blinded to the result of assessment of diaphragmatic function. Periodic assessment will be terminated either if there is NIV success, NIV failure or after 48 hours of treatment with NIV, whichever comes earlier. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients age greater than 18 years
2.Patients presented to ICU with acute respiratory failure
 
 
ExclusionCriteria 
Details  1.Patients requiring emergent endotracheal intubation upon ICU admission prior to recruitment.
2.Patients initiated on NIV in emergency department or ward prior to ICU admission
3.Patients with interstitial lung disease
4.Patients with neuromuscular disease
5.Patients with chest wall deformities
6.Pregnant female
7.NIV Intolerance – Patient refusal for NIV because of NIV discomfort
8.Patients previously on NIV / Home BiPAP
9.Patients who have consented for Do not intubate / Do not resuscitate
10.Terminally ill patients
11.Patients electively intubated for a procedure.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To determine if diaphragmatic thickening fraction can be used to predict NIV failure in patients with acute respiratory failure.  Assessment will be done till there is NIV success, NIV failure or after 48 hours of treatment with NIV, whichever comes earlier. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate diaphragmatic thickening fraction and HACOR score vs HACOR score alone for the prediction of noninvasive ventilation failure in patients with acute respiratory failure.
2. To evaluate diaphragmatic thickening fraction vs HACOR score for the prediction of noninvasive ventilation failure in patients with acute respiratory failure. 
Assessment will be done till there is NIV success, NIV failure or after 48 hours of treatment with NIV, whichever comes earlier. 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   30/05/2025 
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 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  

Noninvasive ventilation (NIV) is a commonly used mode of ventilation in critically ill patients in ICU that significantly reduces the work of breathing in patients with acute respiratory failure. Therefore, NIV might be effective in delaying and overall reducing the need for intubation in patients. Although NIV is commonly used it has a high failure rate of 25 – 59% and delay in detecting NIV failure and subsequent intubation can worsen the patient’s prognosis and increases mortality and duration of hospital stay. Therefore, it is necessary to predict NIV failure at an early stage.

Previous studies have demonstrated the prediction of NIV failure based on components like the patient’s vital signs, level of consciousness, and degree of acidosis. This led to the development of a scale that considers heart rate, acidosis, consciousness, oxygenation, and respiratory rate known as the HACOR scale to predict NIV failure which is defined as the need for intubation after NIV intervention. It is a rapid and convenient tool to effectively predict NIV failure in patients with hypoxemic respiratory failure. HACOR score > 5 is very high risk of NIV failure.

Currently there are no tools validated to objectively assess the effort of breathing during administration of NIV. Point of care ultrasound (POCUS) in the field of critical care medicine has received increased attention because of its rapid availability as a bed side tool, non-invasive, safe and lack of harmful radiation. Respiratory effort can be estimated using ultrasound assessment of the diaphragm. Diaphragmatic thickness, Diaphragmatic thickening fraction (DTF) and Diaphragmatic excursion (DE) are three commonly used tools to assess diaphragm function.

Diaphragm thickening fraction (DTF) is defined as the percentage change in diaphragm thickness during inspiration. Diaphragm thickness fraction (DTF) = (thickness at end-inspiration – Thickness at end-expiration)/Thickness at end expiration × 100. The thickening fraction (TF) represents diaphragm inspiratory activity effort.

The use of bedside ultrasound to study the diaphragmatic thickening fraction can help in early prediction of NIV failure and prevent delayed intubation and the poor outcomes associated with it. The diaphragmatic thickening fraction can further be compared along with HACOR score which is a validated tool for prediction of NIV failure to see if diaphragmatic thickening fraction along with HACOR score can predict NIV failure better than HACOR or thickening fraction alone. Most of the studies till date were conducted in either Emergency department or Respiratory ICU and majority studies were done either on COPD patients or COVID -19 patients which decreases generalizability to other patient population in ICU with acute respiratory failure (Pneumonia, Congestive heart failure, post operative etc). Most of the studies measured DTF only at initiation or for the first 1, 2 hours and not over time in a patient admitted in ICU. Most of the studies done were either pilot study, preliminary study or were small sample size of < 50 patients. None of the studies till date have assessed the efficacy of diaphragm thickening fraction in predicting NIV failure and compared it with HACOR score which is a validated tool for predicting NIV failure. It is not known whether diaphragmatic thickening fraction can be a sensitive test to predict NIV failure in ICU patients with acute respiratory failure and if it can be added on to the HACOR score for better prediction of NIV failure as compared to either HACOR alone or diaphragmatic thickness fraction alone. We postulate that serial measurements of DTF can predict early NIV failure and requirement of intubation in critically ill patients admitted to ICU with acute respiratory failure and can be a valuable tool to combine with HACOR for better prediction of NIV outcome.

 
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