| 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
|
|
|
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
|
|
|
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. |