| 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
|
|
|
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
|
|
|
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 . |