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CTRI Number  CTRI/2025/02/080104 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 04/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Time taken for recovery of breathing after stopping muscle relaxant assessed using ventilator parameter 
Scientific Title of Study   Time taken for recovery of inspiratory effort after Neuromuscular blocking agent (NMBA) administration assessed using P 0.1 and risk factors associated with it : An 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 Avinash Kumar 
Designation  SENIOR RESIDENT 
Affiliation  St Johns Medical College and Hospital 
Address  Dr Avinash Kumar Department of critical care medicine St Johns medical college and hospital Sarjapur road Bengaluru BENGALURU

Bangalore
KARNATAKA
560034
India 
Phone  9031036488  
Fax    
Email  avi292k6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amarja Havaldar 
Designation  Associate Professor 
Affiliation  St Johns Medical College and Hospital 
Address  Dr Amarja Havaldar Associate Professor Department of Critical care medicine St Johns Medical College and Hospital Sarjapur Road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  havaldar.aa@stjohns.in  
 
Details of Contact Person
Public Query
 
Name  Dr Amarja Havaldar 
Designation  Asoociate Professor 
Affiliation  St Johns Medical College and Hospital 
Address  Dr Amarja Havaldar Associate Professor Department of Critical care medicine St Johns Medical College and Hospital Sarjapur Road Bengaluru

Bangalore
KARNATAKA
560034
India 
Phone  9036082112  
Fax    
Email  havaldar.aa@stjohns.in  
 
Source of Monetary or Material Support  
Department of Critical care medicine St Johns medical college and hospital Sarjapur road Bengaluru 560034 Karnataka  
 
Primary Sponsor  
Name  Dr Avinash Kumar 
Address  Department of critical care medicine St Johns medical college and hospital Sarjapur road Bengaluru 560034 Karnataka 
Type of Sponsor  Other [SELF] 
 
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 Amarja Havaldar  St Johns medical college and hospital  Department of Critical care medicine St Johns Medical College and Hospital Sarjapur Road Bengaluru
Bangalore
KARNATAKA 
9036082112

havaldar.aa@stjohns.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ST JOHNS MEDICAL COLLEGE HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B99-B99||Other infectious diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Patients 18 to 80 years
2.Patients who have received single dose or infusion of NMBA
 
 
ExclusionCriteria 
Details  1. Patients with advanced directive of limitation of care (non escalation) after shared decision making
2. Patients with bainstem dysfunction .
3. Patient with neuromuscular weakness or toxidromes affecting neuromuscular function
4. Patients intubated in emergency
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time taken for recovery of inspiratory efforts after neuromuscular blocking agent (NMBA) administration measured by using using P 0.1
 
4 weeks or till ICU discharge
 
 
Secondary Outcome  
Outcome  TimePoints 
1 Time interval between onset of inspiratory effort on controlled mode to initiation of spontaneous mode
2 Duration of ventilation
 
4 weeks or till ICU discharge  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   21/02/2025 
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="8"
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  

Weaning from mechanical ventilation is a multifactorial process. Presence of optimal inspiratory effort after recovery from Neuromuscular blocking agent  (NMBA) is necessary for initiation of weaning . NMBA is used for intubation , preventing
patient – ventilator asynchrony, ARDS or management of raised ICP .

NMBA administration leads to loss of spontaneous inspiratory efforts due to blocking of transmission at neuro-muscular junction, causing paralysis of skeletal muscles. Metabolism and excretion of NMBA  results in recovery from  NMBA effect which leads  to  initiation of spontaneous  inspiratory efforts.

 Time taken for recovery of  inspiratory effort  from NMBA is rarely monitored  in citically ill patients .

Recovery of inspiratory efforts from NMBA can be measured by TOF (train of four) , esophageal pressure  , electrical activity of the diaphragm , performing diaphragmatic ultrasound and P0.1 . Among all the parameters , P0.1 is non invasive , objective and can be measured easily on ventilator .P 0.1  correlates strongly with inspiratory efforts3.

         P 0.1 is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway.

There are no studies regarding the time required to achieve initiation of  inspiratory  effort after administration of neuro-muscular blocking agent( NMBA)  in critically ill patients. The initiation of inspiratory effort translates into optimal inspiratory efforts which in turn leads to initiation of  spontaneous breathing mode.

 This study will record the time duration  between administration of NMBA and  onset of recovery of inspiratory efforts on controlled mode .

The time between onset of optimal inspiratory effort on controlled mode to initiation of spontaneous beathing mode. Risk factors associated with recovery of inspiratory efforts will also  be recorded  .

Insights after analysis can help in formulating pathways for personalised weaning in ICU patients .

 
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