| CTRI Number |
CTRI/2021/07/035139 [Registered on: 26/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to determine the utility of HACOR score as a predictor of weaning off ventilator in ICU |
|
Scientific Title of Study
|
Study to determine the utility of HACOR score as a predictor of successful weaning in mechanically ventilated 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 |
SOUVIK CHAUDHURI |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Critical Care
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
0820-2922033 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
SOUVIK CHAUDHURI |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Critical Care
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
0820-2922033 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
SOUVIK CHAUDHURI |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of Critical Care
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
0820-2922033 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital |
|
|
Primary Sponsor
|
| Name |
Souvik Chaudhuri |
| Address |
Department of Critical Care
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka |
| Type of Sponsor |
Other [Investigator initiated trial] |
|
|
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 Souvik Chaudhuri |
Kasturba Medical Collge 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 are intubated and on mechanical ventilation and are ready to undergo spontaneous breathing trial (SBT). |
|
| ExclusionCriteria |
| Details |
Patients who are deemed unfit clinically for undergoing a spontaneous breathing trial as per the consultant physician will be excluded for the study.
Patients on high vasopressor support and unstable hemodynamics.
Patients with significant electrolyte abnormalities.
Patients with hypothermia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful extubation with non-requirement of re-intubation within 48 hours after extubation |
48 hours after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Days of ICU stay, number of weaning failures. |
30 days after ICU admission |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/08/2021 |
| 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="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients who are mechanically ventilated in ICU will be screened for undergoing spontaneous breathing trial and successful extubation. After the exclusion criteria are ruled out, patients who are successful on spontaneous breathing trial will have the Heart rate, Acidosis from arterial blood gas. Conscoiusness level, Oxygenation, Respirarory Rate (HACOR score) calculated. Arterial blood gas is the standard of care prior to extubation in any mechanically ventilated patient in the ICU, and Acidosis and Oxygenation components of HACOR will be assessed from ABG. The patients will be followed up for need for any ventilatory support upro 48 hours after extubation. The length of ICU stay, final outcome in terms of mortality will also be noted. Correlation will be done to find the utility of HACOR in predicitng successful extubation. |