| CTRI Number |
CTRI/2025/01/079410 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Diaphragmatic Function during NAVA Ventilation An Exploratory Observational Study |
|
Scientific Title of Study
|
Diaphragmatic Function during NAVA Ventilation An Exploratory 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 |
Banani Poddar |
| Designation |
Professor and head of department of critical care medicine |
| Affiliation |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences |
| Address |
Room no-1, second floor, Department of critical care medicine, SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904729 |
| Fax |
05222668017 |
| Email |
bananip@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Saachi SIngh |
| Designation |
DM Critical Care Medicine student |
| Affiliation |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences |
| Address |
CCM ICU 1 and 2, first floor, Department of Critical care Medicine, SGPGIMS, Lucknow
UTTAR PRADESH
226014
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004903793 |
| Fax |
05222668017 |
| Email |
saachisingh0@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Banani Poddar |
| Designation |
Professor and head of department of critical care medicine |
| Affiliation |
Sanjay Gandhi Post Graduate Institute Of Medical Sciences |
| Address |
Room no-1, second floor, Department of critical care medicine, SGPGIMS, Lucknow
Lucknow
UTTAR PRADESH
226014
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8004904729 |
| Fax |
05222668017 |
| Email |
bananip@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow -226014 INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Not applicable |
| Type of Sponsor |
Other [Nil] |
|
|
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 Banani Poddar |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Room no 1, second floor, Department of Critical Care Medicine, SGPGI, Lucknow - 226014
Lucknow
UTTAR PRADESH Lucknow UTTAR PRADESH |
8004904729
bananip@sgpgi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age more than 18 years
2.Patient on ventilator for more than 7 days
3.Ready for pressure support ventilation as assessed by bedside clinician |
|
| ExclusionCriteria |
| Details |
1.Patients with oesophageal, maxillofacial pathology or trauma preventing OG or NG tube insertion
2.Patients of severe neuropathy affecting phrenic nerve function, or active neuromuscular diseases, encephalopathy
3.Patients who have hemodynamic instability or are not ready for weaning
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in neuro-ventilatory efficiency by NAVA ventilation |
4 days after ventilation with NAVA mode |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weaning from ventilator |
One week from inclusion in trial |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
04/02/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diaphragm is a fundamental respiratory muscle whose dysfunction is common in critically ill patients. In recent years ultrasonography has emerged as a new method for assessment of diaphragmatic function and is considered better than other methods. Diaphragmatic ultrasound is a non invasive, cost effective, safe and easy to perform technique that allows a morphological and functional evaluation of diaphragm in real time and can be repeated at the bedside. Two diaphragm sonographic features are associated with the outcome of weaning; the diaphragmatic excursion which measures the distance that the diaphragm is able to move during the respiratory cycle and the diaphragm thickening fraction which reflects the change in the thickness of the diaphragm during a respiratory effort. Neurally adjusted ventilator assist, a mode of ventilation was first described in 1998 by Sinderby et al. It is a mode of ventilator that detects diaphragmatic electrical activity via an adapted nasogastric tube and uses this diaphragmatic electrical activity to drive the ventilator. The diaphragmatic electrical activity (EAdi) offers an insight into a patient’s respiratory drive and neural demand for ventilatory support. Most of the studies on NAVA are in newborns where NAVA has shown reduced patient ventilator asynchrony, better gas exchange and reduced respiratory muscle load. A sizeable number of our ICU patients are ventilated for prolonged periods and many of them have neuromuscular weakness. In this background we wanted to study diaphragmatic function during NAVA mode of ventilation in patients who have been on prolonged mechanical ventilation. We would like to explore if NAVA mode of ventilation would lead to an improvement in diaphragm thickness fraction and excursion of diaphragm in such patients. Following approval by the Institutional Ethics Committee, the study would be conducted in 25 adult patients (18-65yrs) of either sex in ICU having prolonged ventilation (>7 days), after taking written and informed consent from the patient’s relatives. The study would be completed in a period of 18 months.
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