| CTRI Number |
CTRI/2024/07/069798 [Registered on: 02/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Predicting mechanical ventilation duration during Lung Injury Prediction Score in adult ICU patients |
|
Scientific Title of Study
|
Lung Injury Prediction Score in predicting the duration of invasive mechanical ventilation in adult intensive care patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashwin Ramesh CB |
| Designation |
Senior Resident |
| Affiliation |
Bharati Hospital and Research Center, Pune |
| Address |
Department of Critical Care Medicine, Bharati Hospital and Research Center, Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9003194533 |
| Fax |
|
| Email |
ashwin3190@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jignesh Shah |
| Designation |
Professor |
| Affiliation |
Bharati Hospital and Research Center,Pune |
| Address |
Department of Critical Care Medicine, Bharati Hospital and Research Center, Pune
Pune
MAHARASHTRA
4110443
India |
| Phone |
9028246946 |
| Fax |
|
| Email |
jignesh.shah@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jignesh Shah |
| Designation |
Professor |
| Affiliation |
Bharati Hospital and Research Center,Pune |
| Address |
Department of Critical Care Medicine, Bharati Hospital and Research Center, Pune
Pune
MAHARASHTRA
4110443
India |
| Phone |
9028246946 |
| Fax |
|
| Email |
jignesh.shah@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre, Pune Satara Road, Pune, India 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research CentrePune |
| Address |
Department of Critical Care Medicine,Bharati Hospital and Research Centre,Pune Satara Road, Pune, Maharashtra,India 411043 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrAshwin Ramesh CB |
Bharati Hospital and Research Center,Pune |
SSICU1 and SSICU3,Department of Critical Care Medicine, Bharati Hospital and Research Center,Satara Road, Dhankawadi, Katraj,Pune,India 411043
Pune
MAHARASHTRA |
9003194533
ashwin3190@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth(Deemed to be University)Institutional Ethics Committee |
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 |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients in intensive care medicine
2. Mechanically ventilated for more than 24 hours |
|
| ExclusionCriteria |
| Details |
1. age less than 18 years
2. mechanically ventilated for less than 24 hours |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of invasive mechanical ventilation |
7 days, 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality, Duration of ICU stay, weaning |
7 days |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
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)
|
10/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Invasive mechanical ventilation is defined as the delivery of positive pressure to the lungs via an endotracheal or tracheostomy tube. Approximately 5–13% of patients with acute respiratory failure require Prolonged Mechanical Ventilation, and a trend of increasing PMV exists worldwide Recognized factors of weaning failure are underlying respiratory diseases, previous ICU admissions, a high acute physiology and chronic health evaluation (APACHE II) score, and pneumonia[5].Other factors related to unsuccessful weaning are elevated blood urea nitrogen levels, low Glasgow coma scale (GCS) scores, low serum albumin, and low maximal inspiratory pressure levels
Lung Injury Prediction Score consists of various parameters which are correlated with ARDS development which are linked to increased duration of mechanical ventilation hence study is done to determine duration of mechanical ventilation using Lung Injury Prediction Score
|