| CTRI Number |
CTRI/2022/03/040965 [Registered on: 10/03/2022] Trial Registered Prospectively |
| Last Modified On: |
05/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Chest muscle function in patients during removal from ventilator in ICU |
|
Scientific Title of Study
|
Determination of parasternal intercostal muscle activity in critically
ill patients with various weaning patterns and its association with weaning-induced pulmonary oedema (WIPO) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Souvik Chaudhuri |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Critical Care,
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Souvik Chaudhuri |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Critical Care,
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Souvik Chaudhuri |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Critical Care,
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Souvik Chaudhuri |
| Address |
Department of Critical Care, Kasturba Medical College, Madhav Nagar, Manipal, Karnataka |
| Type of Sponsor |
Other [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 |
| Souvik Chaudhuri |
Kasturba Medical College and Kasturba Hospital, Manipal |
Department of Critical Care, First floor, Trauma and Emergency Block
Udupi
KARNATAKA |
9937178620
souvik.chaudhuri@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J962||Acute and chronic respiratory failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were mechanically ventilated in ICU
and meet the following criteria will be put on SBT for weaning will be included.
Following will be the criteria to consider for weaning in the ICU which is used by any
intensivist at our institute:
1. Fraction of inspired oxygen (FiO2 < 0.5)
2. Positive end expiratory pressure (PEEP) ≤ 5cmH2O
3. Partial pressure of oxygen in arterial blood (PaO2)/FiO2 > 150 mmHg
4. Respiratory rate < 35/minute
5. Tidal volume >5mL /kg,
6. Minute ventilation < 10L/min
7. No abnormality in electrolyte parameters, absence of hemodynamic instability, resolution
of the initial cause of ventilator requirement and patients awake with the ability to cough. |
|
| ExclusionCriteria |
| Details |
1. Patients with chest wall abnormalities,
2. Distorted chest wall anatomy,
3. Patients with any known neuromuscular weakness, 4. Patients with any known diaphragmatic disorders
5. Pregnant patients,
6. Patients with known cardiac dysfunction on initial ECHO during hospital admission
7. Any patient in whom the SBT is aborted even before 30 minutes duration as deemed by the intensivist will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful weaning from ventilator |
48 hours after removal of ventilator |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Survival of ICU stay |
28 days from day of admission to ICU |
|
|
Target Sample Size
|
Total Sample Size="145"
Sample Size from India="145"
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)
|
25/03/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Mechanically ventilated patients who are fitting the inclusion and exclusion criteria will be included for this study. The duration of spontaneous breathing trial (SBT) will be 120 minutes as per the protocol at our institute. Just before initiation of SBT, the patient will be evaluated by bedside ultrasound for the lung ultrasound score for presence of pulmonary oedema, cardiac function ( systolic and diastolic function). Patients who tolerate at least 30 minutes of SBT will be evaluated for lung ultrasound for evidence of weaning induced pulmonary oedema (WIPO), bedside echocardiography (systolic and diastolic dysfunction) and parasternal muscle thickening and parasternal muscle thickening fraction. Diaphragmatic excursion and diaphragmatic thickening fraction will also be noted. At the end of 120 minutes of SBT, whether or not the patients are getting successfully off ventilator support as per the treating intensivist, will be noted. The patients who fail even 30 minutes of SBT, the following parameters will be noted after the patient is put back on previous ventilatory support as per the treating intensivist- lung ultrasound for evidence of pulmonary oedema, systolic and diastolic function as per echocardiography. The patients who fail SBT for the first time, will be followed for the subsequent 3 SBT for the same parameters as outlined above for the first SBT. The number of SBT required for successful weaning from ventilator will be noted. Patients who are removed from ventilator after SBT success at 120 minutes will be followed for next 48 hours to see if they require invasive ventilator support/ intubation again. Outcome of the ICU stay at 28 days will be noted - survival or mortality. |