| CTRI Number |
CTRI/2023/09/057314 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
10/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To take patient off breathing machine support (Ventilator)by examining breathing muscle (diaphragm) with ultrasound. |
|
Scientific Title of Study
|
Predictive value of diaphragmatic kinetics using tissue doppler imaging in weaning of patients from mechanical ventilation- An observational, prospective cohort 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 |
Priya Gole |
| Designation |
DrNB Resident |
| Affiliation |
Medanta - The Medicity, Gurugram |
| Address |
Medanta Institute of Critical Care and Anaesthesiology
Gurgaon HARYANA 122001 India |
| Phone |
9325012811 |
| Fax |
|
| Email |
priya.priyagole@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman- Critical Care |
| Affiliation |
Medanta - The Medicity, Gurugram |
| Address |
Medanta Institute of Critical Care and Anaesthesiology
Gurgaon HARYANA 122001 India |
| Phone |
9818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman- Critical Care |
| Affiliation |
Medanta - The Medicity, Gurugram |
| Address |
Medanta Institute of Critical Care and Anaesthesiology
Gurgaon HARYANA 122001 India |
| Phone |
9818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Medanta,The Medicity, Gurgaon |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Priya Gole |
Medanta Institute of Critical Care and Anaesthesiology, Medanta - The Medicity, Gurugram |
Medanta Institute of Critical Care and Anaesthesiology, Medanta - The Medicity,
Sector 38, Gurugram, Gurgaon HARYANA |
9325012811
priya.priyagole@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: J986||Disorders of diaphragm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
(1) Age ≥ 18 years
(2) On mechanical ventilation for more than 12 h
(3) Meeting all of the following criteria for the SBT:
a. FiO2<40%
b. Positive end-expiratory pressure ≤5 cmH2O
c. Respiratory rate≤30 breaths/min
d. Haemodynamic stability in the absence/ minimal vasopressors
|
|
| ExclusionCriteria |
| Details |
1. Age <18 years
2. Neuromuscular diseases
3. Flail chest or multiple rib fracture
4. Morbid obesity (BMI> 40 kg/m2)
5. Inability to obtain a clear TDI signal of the right hemidiaphragm
6. Pregnant patient.
7. Tracheostomised patient
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation of diaphragmatic kinetics (Peak contraction velocity, peak relaxation velocity, velocity time integral, maximal relaxation rate) with weaning |
Just before the Spontaneous Breathing Trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of reintubation within 48 hours of extubation. |
Within 48 hours of extubation. |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
20/09/2023 |
| 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)
Modification(s)
|
Not Applicable |
| 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 step during recovery from critical illness. Weaning failure or early reintubation are associated with increased morbidity and mortality, exposing patients to life-threatening complications. Weaning from mechanical ventilation involves change of positive pressure ventilation to negative pressure ventilation during spontaneous breathing trail (SBT)
Diaphragm function is an important determinant of successful liberation from ventilation and recovery from critical illness. Invasive mechanical ventilation causes progressive decline in diaphragm bulk and strength in a phenomenon called ventilator induced diaphragm dysfunction [VIDD]. Our hypothesis is that diaphragmatic kinetic parameters differ between patients who have successful weaning as compared to patients with weaning failure and thus, diaphragmatic tissue doppler imaging (TDI) variables can be used as an adjuvant to spontaneous breathing trial (SBT). Ultrasound is easily available in all the intensive care units. It is non-invasive, with no radiation effects, patient and intensivist friendly, can be repeated multiple times if necessary.Patient safety is not compromised and can be done at bed side. Patient need not be shifted out of ICU for any assessment. Patients who are ≥ 18 years, on mechanical ventilation for more than 12 h and meeting all of the following criteria for the SBT are included On each TDI waveform following parameters will be identified and measured –Peak contraction velocity (PCV),Velocity–time integral (VTI), Peak relaxation velocity (PRV),Maximal relaxation rate (MRR) Objective is to compare diaphragmatic kinetics using tissue doppler imaging (peak contraction velocity, velocity time integral, peak relaxation velocity, maximal relaxation rate) in patients who had a successful weaning versus patients who had a weaning failure. |