| 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
|
|
|
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
|
|
|
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. |