| CTRI Number |
CTRI/2022/04/041810 [Registered on: 12/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Using Abdominal expiratory muscle thickness to estimate successful withdrawal of mechanical ventilation in critically ill patients |
|
Scientific Title of Study
|
Abdominal Expiratory Muscle Thickness as a Predictor of Successful Weaning in Critically Ill Patients on Mechanical Ventilation: 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 |
Dr Pooja C S |
| Designation |
Junior resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Anaesthesiology, room No 026604, level 6, All India institute of medical sciences,Virbhadra Marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9110686619 |
| Fax |
|
| Email |
poojaiyengar007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Additional professor |
| Affiliation |
All India institute of medical sciences, Rishikesh |
| Address |
Department of Anaesthesiology room No. 026604, level 6, All India institute of medical sciences,Virbhadra marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaurav Jain |
| Designation |
Additional Professor |
| Affiliation |
All India institute of medical sciences, Rishikesh |
| Address |
Department of Anaesthesiology, room NO. 026604, level 6, All India institute of medical sciences, Virbhadra marg, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8808631209 |
| Fax |
|
| Email |
gauravhld@gmail.com |
|
|
Source of Monetary or Material Support
|
| Critical care unit, AIIMS Rishikesh |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
Not applicable |
| Type of Sponsor |
Other [Other ( not applicable)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| None |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| POOJA C S |
All India institute of medical sciences, RISHIKESH |
Critical care unit,room no 026604, Department of Anaesthesiology,AIIMS RISHIKESH
Dehradun
UTTARANCHAL |
9110686619
poojaiyengar007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe, AIIMS Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasonography of abdominal expiratory muscles |
Ultrasonographic assessment will be performed by using a B-mode Ultrasound device connected to 7 to 12 MHz linear probe and abdominal expiratory muscle thickness will be measured at 3 time points - on ICU admission, at 72hrs, just before Spontaneous breathing trial in ready to wean patients. |
| Intervention |
Ultrasonography of Diaphragm |
Ultrasonographic assessment will be performed by using a B-mode Ultrasound device connected to 7 to 12 MHz linear probe and diaphragm thickness will be measured at 3 time points - on ICU admission, at 72hrs, just before Spontaneous breathing trial in ready to wean patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1)Age>18 years.
2)Requiring invasive mechanical ventilation at ICU admission.
3)Expected duration of mechanical ventilation >72 hours.
4)Ready to undergo spontaneous breathing trial |
|
| ExclusionCriteria |
| Details |
Past history of neuromuscular disorders
Mechanical ventilation>48 hrs within current hospital admission
Obesity (BMI>35)
Pregnant women
Abdominal wound at proposed location of ultrasound probe due to recent abdominal surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Abdominal expiratory muscle thickness as a predictor of successful weaning in ready to wean critically ill patients receiving mechanical ventilation. |
At admission
At 72 hours
Just before Spontaneous breathing trial in ready to wean patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between change in expiratory muscle and diaphragmatic thickness in critically ill patients receiving mechanical ventilation. |
At admission
At 72 hours
Just before Spontaneous breathing trial in ready to wean patients |
| Factors predicting change in abdominal expiratory muscle thickness in critically ill mechanically ventilated patients. |
During ICU stay |
| To assess time dependent changes of expiratory muscle thickness in critically ill mechanically ventilated patients |
At admission
At 72 hours
Just before Spontaneous breathing trial in ready to wean patients |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/04/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Weaning is the process of withdrawing mechanical ventilator support and transferring the work of breathing from ventilator to the patient. Failure of weaning from mechanical ventilation is a common problem faced in ICU, and several methods have been developed to predict weaning failure. The abdominal wall muscles are critical for protective reflexes such as coughing and thus may affect weaning in patients on mechanical ventilator. The aim of our study is to evaluate the thickness of abdominal expiratory muscles as a predictor of successful weaning in ready to wean critically ill patients on mechanical ventilation. |