FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078805 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Whether respiratory muscle action can tell us if we can remove ventilatior in patients who are seriously ill 
Scientific Title of Study   Prediction of Weaning Outcome by Diaphragmatic Surface Electromyography: 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  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5013, Teaching Block, All India Institute of Medical Sciences
Ansari Nagar
South
DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5013, Teaching Block, All India Institute of Medical Sciences
Ansari Nagar

DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Details of Contact Person
Public Query
 
Name  Dr Souvik Maitra 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  5013, Teaching Block, All India Institute of Medical Sciences
Ansari Nagar

DELHI
110029
India 
Phone  8146727891  
Fax    
Email  souvikmaitra@live.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029 India 
 
Primary Sponsor  
Name  Dr. Souvik Maitra 
Address  5013, Teaching Block Department of Anaesthesiology, Pain Medicine & Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110019 
Type of Sponsor  Other [Principal Investigator] 
 
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 Souvik Maitra  All India Institute of Medical Sciences, New Delhi  AB8 ICU, Main Block, Department of Anaesthesiology, Pain Medicine & Critical Care, All India Institute of Medical Sciences, Ansari Nagar, New Delhi- 110029
South
DELHI 
8146727891

souvikmaitra@live.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J96||Respiratory failure, not elsewhereclassified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Not applicable 
Comparator Agent  Nil  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Critically ill patients with a diagnosis of respiratory failure, duration of mechanical ventilation of more than 48 hrs and eligible for a SBT as decided by the intensivist.
 
 
ExclusionCriteria 
Details  1. Pregnancy
2. Patients with spinal cord injury
3. Presence of significant arrhythmias
4. Patients with diaphragmatic paralysis/injury
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether non- invasively measured diaphragmatic surface electromyography (sEMG) is useful in predicting weaning failures within 48 hours of extubation in critically ill patients.   To determine whether non- invasively measured diaphragmatic surface electromyography (sEMG) is useful in predicting weaning failures within 48 hours of extubation in critically ill patients.  
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine the possibility of a composite index made up of patients demographic, baseline disease severity and fluid balance with diaphragmatic sEMG for predicting weaning outcomes.
2. To determine predictive ability of sEMG for SBT outcome.
 
At 48hours 
 
Target Sample Size   Total Sample Size="129"
Sample Size from India="129" 
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)   03/02/2025 
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="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 - NO
Brief Summary  

All patients who satisfy the inclusion criteria will be included in the study after obtaining a written informed consent from the patients next of kin. When an SBT is planned by the treating physician, the investigator will perform the ultrasound measurements. First, the patients’ demographic characters like age, sex, nature of ICU (Medical /Surgical), presence of comorbid condition, primary diagnosis of the patient, indication of ICU admission, APACHE II and SOFA scores at ICU admission, duration of ICU stay, duration of mechanical ventilation prior to the SBT will be recorded. Baseline hemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), mean arterial pressure (MAP), diastolic blood pressure (DBP), oxygen saturation (SpO2), type of respiratory support, PaO2/FiO2 ratio, cumulative fluid balance after ICU admission at the time will also be noted.

Immediately before SBT, sEMG of diaphragm will be noted from two surface electrode by a commercially available sEMG device (PheezeeⓇ, Sartoon Labs). Another sets of reading of sEMG will be obtained as the end of SBT protocol irrespective of the decision of extubation. All patients will be followed 48 hours after extubation to note requirement of oxygen therapy (oxygen by face mask, non-invasive ventilation and HFNC) and requirement for re-intubation within 48 hours. 

 
Close