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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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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