| CTRI Number |
CTRI/2025/02/081108 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see if a new test Electrical Impedance Tomography is better than usual methods at predicting whether patients can breathe on their own after ventilator being removed. |
|
Scientific Title of Study
|
A prospective observational study to compare electrical impedance tomography parameter with
conventional parameters in the prediction of spontaneous
breathing trial success |
| 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 Aditi Yadav |
| Designation |
DrNB Fellow |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesiology Sector 38 Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
8447099275 |
| Fax |
|
| Email |
aditiyadav1187@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Tyagi |
| Designation |
Consultant Critical Care |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesiology Sector 38 Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
8860037475 |
| Fax |
|
| Email |
poojatyagi1919@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Yadav |
| Designation |
DrNB Fellow |
| Affiliation |
Medanta The Medicity |
| Address |
Institute of Critical Care and Anesthesiology Sector 38 Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
08447099275 |
| Fax |
|
| Email |
aditiyadav1187@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana
122001 |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Yadav |
| Address |
Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana
122001 |
| 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 Aditi Yadav |
Medanta The Medicity |
Institute of Critical Care and Anesthesiology 2nd Floor ICU 9 10 11 12 Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA |
8447099275
aditiyadav1187@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J958||Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Age more than 18 years
2 On invasive mechanical ventilation for more than 24 hours who are eligible to undergo SBT
3 GCS more than 12
4 Presence of cough during suctioning and need for infrequent tracheal suctioning
5 PaO2 FiO2 ration more than equal to 200 mm Hg with PEEP less than equal to 5 cm H2O and FiO2 less than equal to 0.4
6 Stable cardiovascular status
|
|
| ExclusionCriteria |
| Details |
1 Presence of chest burn
2 Pregnancy
3 Recent within one week thoracic surgery or chest trauma
4 Patients with pneumothorax or surgical emphysema |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A novel parameter to predict SBT success |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To predict extubation success |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
14/03/2025 |
| 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 Yet Recruiting |
| 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
|
Weaning from mechanical ventilation is a challenging part of intensive care management. Spontaneous Breathing Trial (SBT), is a common method performed in the assessment of readiness for extubation. Certain conventional objective parameters like Negative Inspiratory force (NIF) and Rapid Shallow Breathing Index (RSBI) are assessed during SBT to predict weaning outcome. These parameters determine different aspects of respiratory muscle dynamics and respiratory drive, and help in assessment of readiness for extubation. Electrical impedance tomography (EIT) is a non-invasive imaging modality that provides a dynamic image of the distribution of air inside the lungs based on changes in electrical impedance. This study is to compare electrical impedance tomography parameter and conventional parameters in the prediction of spontaneous breathing trial success. |