| CTRI Number |
CTRI/2025/08/092591 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find number of critially ill patients developing diaphragm dysfunction after mechanical ventilation |
|
Scientific Title of Study
|
Ventilator Induced Diaphragmatic dysfunction in critically ill mechanically ventilated children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naavendan R |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
PICU
Department of Pediatrics
Maulana Azad medical college and Lok nayak Hospital
2,Bahadurshah Zafar Marg,
New Delhi
110002
Delhi
India
Central
DELHI
110002
India |
| Phone |
9994740851 |
| Fax |
|
| Email |
naavendanravi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRomit Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
PICU
Department of Pediatircs
Maulana Azad Medical College and Lok nayak Hospital
2,Bahadurshah Zafar Marg,
New Delhi
110002
Delhi
India
Central
DELHI
110002
India |
| Phone |
9597650364 |
| Fax |
|
| Email |
drromit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRomit Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
PICU
Department of Pediatircs
Maulana Azad Medical College and Lok nayak Hospital
2,Bahadurshah Zafar Marg,
New Delhi
110002
Delhi
India
Central
DELHI
110002
India |
| Phone |
9597650364 |
| Fax |
|
| Email |
drromit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical college
2,Bahadurshah Zafar Marg
New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
2,Bahadurshah Zafar Marg,
New Delhi
110002
Delhi
India |
| 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 |
| DrNaavendan R |
Lok Nayak Hospital |
PICU
Department of Pediatrics
Maulana Azad medical college and Lok Nayak Hospital
2,Bahadurshah Zafar Marg,
New Delhi
110002
Delhi
India
Central
DELHI |
9994740851
naavendanravi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak ,GB Pant Institute of Postgraduate Medical Education and Research Hospital,Guru Nanak Eye Centre,New Delhi-110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J708||Respiratory conditions due to other specified external agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between 1 month to 12 years requiring mechanical ventilation
2.Mechanical ventilation for more than 24 hours
3.Admission to Pediatric intensive care unit or Pediatric High dependency unit in department of Pediatrics, MAMC and associated LN Hospital
|
|
| ExclusionCriteria |
| Details |
1.Children with known diagnosis of Myasthenia Gravis, Guillian barre syndrome, Amyotropic lateral sclerosis, Cervical spinal cord injury, and Spinal muscular atrophy, bronchopleural fistula.
2.Children those who were ventilated for more than 24 hours prior to presentation into Intensive care unit.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patient with Ventilator Induced diaphragmatic dysfunction in Mechanically ventilated patient |
2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Factors associated with causation of Ventilator induced diaphragm dysfunction including muscle wasting (as assessed by QFMT, skin fold thickness), inotrope requirement (as assessed by mean vasoactive inotropic score), oxygen requirement (as assessed by mean oxygenation index ), calorie intake, presence of AKI, delay in starting feeds, drug associated sarcopenia, dyselectrolytemia, ventilation parameters etc. |
2 week |
| 2. Association of Ventilator induced diaphragmatic dysfunction with clinical outcomes such as mortality, duration of stay, duration of ventilation etc. |
2 week |
| 3. Diaphragmatic thickness fraction ratio as a predictor of success of spontaneous breathing trial and extubation success. |
2 week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [naavendanravi@gmail.com].
- For how long will this data be available start date provided 05-12-2026 and end date provided 05-12-2036?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Mechanical ventilation is a life saving intervention
which aims at exchange of gases totally or partially compensating for the lung.
However it is associated with Diaphragmatic muscle injury (myotrauma) leading
to diaphragmatic dysfunction. The
incidence of ventilator associated diaphragmatic dysfunction helps in
identifying the percentage of intubated children prone to develop diaphragmatic
dysfunction. There is no single specific
cause for ventilator associated diaphragmatic dysfunction, multiple factors and
multiple pathophysiology are proposed for its cause. The ventilator induced
diaphragmatic dysfunction(VIDD) plays an important role in modifying the
outcome of the patient in the extubation trials and the course of stay in intensive
care unit. The ultrasound guided assessment of diaphragmatic function is a
useful bedside point of care tool , that can be used to identify patients with ventilator associated
diaphragmatic dysfunction, and has shown good accuracy and reproducibility. It
gives an additional advantage of non invasive assessment of diaphragmatic
function. Through this study we shall prospectively assess
diaphragmatic dysfunction serially in intubated children. Concomitantly we
shall assess parameters which may lead to causation of VIDD as muscle wasting
(through quadriceps femoris muscle thickness), presence of shock (mean VIP),
ischemia (mean OI/OSI), nutrition and ventilation (ventilation settings). |