| CTRI Number |
CTRI/2020/12/029533 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
A Study to determine the efficiency of a specific modality of ultrasound (tissue doppler imaging) in imaging an abddominal muscle (diaphragm) to predict if patients can be successfully liberated from ventilator |
|
Scientific Title of Study
|
Efficacy Of Diaphragmatic Tissue Doppler Imaging Parameters In Predicting Weaning Outcomes In Critically Ill Patients
A prospective observational study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gautham Chandran |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department Of Anaesthesia and critical care
All India Institute Of Medical Sciences,
Sri Aurbindo Marg,
Ansari nagar east,New Delhi 110029
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
gautham.chandran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Ranjan Ray |
| Designation |
Associate Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Anaesthesia and Critical care,
All India Institute Of Medical Science
Sri Aurobindo Marg, Ansari Nagar, , New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gautham Chandran |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
Department of Anaesthesia and critical care,
All India Institute Of Medical Sciences
Sri Aurobindo Marg, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
gautham.chandran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gautham Chandran |
| Address |
Department Of Anaesthesia and critical care
All India Institute Of Medical Sciences,
Sri Aurbindo Marg,
Ansari nagar east,New Delhi 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Gautham Chandran |
All India Institute Of Medical Sciences |
Department Of Anaesthesia and critical care
Sri Aurbindo Marg,
Ansari nagar east,New Delhi 110029
South
DELHI |
9004978187
gautham.chandran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCHT, ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
On mechanical ventilation >48hrs.
Readiness for weaning from mechanical ventilation
Recovery from the cause of respiratory failure
Stable hemodynamic parameters.
Low or no vasopressor requirement
No sedative agents or NMBA > 24 h before enrolment.
Patients who meet criteria for spontaneous breathing trial
Fio2 < 40
Pressure Support (PS) < 10
Positive End Expiratory Pressure (PEEP) <
Respiratory Rate <30
P/F ratio >200
Glasgow coma scale - GCS >14 ,
RASS: -2 to +2.
|
|
| ExclusionCriteria |
| Details |
Pregnant Women
Presence of Pneumothorax or Ascites
H/o either neuromuscular disease, thoracic surgery, Diaphragmatic Palsy, Cervical Spine Injury
Weaning failure definitely caused by upper airway obstruction
Planned prophylactic NIV after extubation.
Poor ultrasound windows and image
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the diagnostic accuracy of diaphragmatic pulse-wave tissue doppler imaging (PW-TDI) parameters in predicting weaning outcomes in critically ill mechanically ventilated patients |
Ultrasound measurements will be taken at the end of a 60 minute spontaneous breathing trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of hospital stay.
|
total duration of stay in hospital |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A propsective observational study aimed at determining the utility of a specific mode of ultrasound (Tissue Doppler Imaging) in predicting weaning in critically ill patients receiving mechanical ventilation in ICU. Enrollment not started study duration approximately 2 years study size 40 Institute Ethics committe approval received on 22.7,20 |