| CTRI Number |
CTRI/2024/01/061846 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Diaphragm Parameters by Ultrasound to Predict Weaning from Mechanical Ventilation |
|
Scientific Title of Study
|
Sonographic Assessment of Diaphragmatic Indices for Predicting Weaning in Patients on Mechanical Ventilation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirankumar C |
| Designation |
Senior Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesia and Critical Care Medicine
VMMC and Safdarjung Hospital
New Delhi DELHI 110029 India |
| Phone |
7010403313 |
| Fax |
|
| Email |
kirankumar.c2009@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Poonam Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesiology and Critical Care
VMMC and Safdarjung Hospital
Ansari Nagar East
New Delhi DELHI 110029 India |
| Phone |
9818623450 |
| Fax |
|
| Email |
p.gupta182@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Poonam Gupta |
| Designation |
Senior Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anesthesiology and Critical Care
VMMC and Safdarjung Hospital
Ansari Nagar East
New Delhi DELHI 110029 India |
| Phone |
09818623450 |
| Fax |
|
| Email |
p.gupta182@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Sadarjung Hospital |
| Address |
ansari nagar west,
New Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Kirankumar C |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anesthesiology and Critical Care
Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar East
New Delhi DELHI |
7010403313
kirankumar.c2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vardhman Mahavir Medical College and Safdarjung Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1-Age > 18 years
2-On mechanical ventilator ≥48 hours
|
|
| ExclusionCriteria |
| Details |
1-History of neuromuscular disease, diaphragmatic palsy, thoracic surgery, any mass or mechanical factor in chest or abdomen
2-Low Glasgow coma score
3-Pregnancy, ascites, morbid obesity
4-Increased intra-abdominal pressure.
5-Lung collapse and large pleural effusion
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the accuracy of diaphragmatic indices (Diaphragm excursion, Time to peak amplification, and diaphragm thickness fraction) by ultrasonography to predict successful weaning in patients on mechanical ventilation.
2.To evaluate the best measured variables to predict successful weaning .
|
At the time, just before extubation of the patient from mechanical ventilator. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare diaphragmatic parameters with Rapid shallow breathing index (RSBI).
2.To assess the association between diaphragmatic indices & diaphragmatic dysfunction & reintubation
3.To assess the patients’ characteristics like age, sex, SOFA score, APACHE II score, type of mode of mechanical ventilation & comorbidities for diaphragm dysfunction and
4.To assess the duration on mechanical ventilation & ICU stay.
|
At the time, just before extubation of the patient from mechanical ventilator.
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
01/02/2024 |
| 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="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
|
A great
number of critically ill patients in intensive care unit require invasive
mechanical ventilation as a part of their care.
Despite being life savior, liberation from ventilator is very challenging and
time consuming. Untimely discontinuation of mechanical ventilation may lead to
amplified cardiovascular and respiratory stress, CO2 retention and hypoxemia with up to 25% of patients requiring reinstitution of
ventilator support. Unnecessary delays in weaning from mechanical ventilation can also be deleterious. Complications
such as ventilator associated
pneumonia and ventilator induced diaphragm atrophy can be seen even with short periods
of mechanical ventilation thereby
prolonging mechanical ventilation.
Nevertheless,
mechanical ventilation or the underlying ailment can lead to diaphragmatic dysfunction, a condition
that may contribute to weaning failure. Extended time on the
ventilator greatly increases patient morbidity and mortality. Symptoms and signs of muscle disease in ICU patient are
often difficult to evaluate because of concomitant
confounding factors. Weaning is a continuous process, which starts with
recognition of patient being ready to be
weaned off from ventilator. Several parameters such as rapid shallow breathing
index, vital capacity and maximum peak inspiratory pressure are being used
routinely to extubate a patient from mechanical ventilator but the sensitivity,
specificity, positive predictive value, and negative predictive values are
highly variable. Moreover, these parameters do not assess the diaphragm
dysfunction which is the major respiratory muscle and prime cause for the
weaning failure.
Conservative
assessment of diaphragm function lacks specific, noninvasive, time-saving, and
easily performed bedside tools or requires patient
cooperation. In recent times, the use of ultrasound has risen as a simple, noninvasive method of quantification of diaphragmatic
excursion and contractile activity.
Ultrasonography is a feasible, relatively inexpensive, radiation-free imaging
modality which allows the
visualization of muscle contractions; and has been shown to used successfully
at bedside to evaluate diaphragm dysfunction, which is taken to be
diaphragmatic excursion < 10mm and diaphragmatic
thickness fraction <30%. It can distinguish between diaphragmatic paralysis, paradoxical upward movement,
or immobility of the diaphragm.
Hence,
we aim to assess the diaphragmatic indices by ultrasound for predicting weaning outcome in patients on
mechanical ventilation in the ICU setting. |