| CTRI Number |
CTRI/2024/03/064644 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
23/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of different mortality score as a determinant for artificial respiratory support in critical care unit. |
|
Scientific Title of Study
|
Comparison of APACHE IV , SAPS III and SOFA score as a determinant for post-extubation artificial respiratory support in critical care unit. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Asrarul Haque Siddiqui |
| Designation |
Post graduate Junior resident (Anaesthesiology) |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Critical care unit , 2nd Floor , Trauma and Emergency building , gate no-2 , Tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
6006172395 |
| Fax |
|
| Email |
nehal.helal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chinmaya kumar panda |
| Designation |
Associate professor , Department of Anaesthesiology |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Critical care unit , 2nd floor , Trauma and Emergency building , gate no 2, AIIMS campus ,tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
8098007711 |
| Fax |
|
| Email |
chinmaya.panda06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Asrarul haque siddiqui |
| Designation |
Post graduation junior resident (Department of Anaesthesiology) |
| Affiliation |
All India Institute of Medical Sciences , Raipur |
| Address |
Critical care unit , 2nd floor , Trauma and Emergency building , gate no 2 , AIIMS campus , tatibandh
Raipur
CHHATTISGARH
492099
India |
| Phone |
6006172395 |
| Fax |
|
| Email |
nehal.helal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Crirical care unit , Department of Anaesthesiology , AIIMS Raipur. |
|
|
Primary Sponsor
|
| Name |
AIIMS RAIPUR |
| Address |
Critical care unit ,2nd floor , Trauma and Emergency building , Gate no 2 , AIIMS Campus , Tatibandh , Raipur . PIN-492099 , Chhattisgarh |
| Type of Sponsor |
Government 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 |
| Dr Md Asrarul Haque Siddiqui |
All India Institute Of Medical Sciences, Raipur |
Critical care unit , 2nd floor , Trauma and Emergency building , gate no 2 , AIIMS campus , tatibandh
Raipur
CHHATTISGARH |
6006172395
nehal.helal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee , AIIMS Raipur |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are admitted in Critical care unit for need of mechanical ventilation for minimum of 24 hours , belonging to ASA grade I to IV and above 18 years of age (at the time of enrolment) will be included in this study. |
|
| ExclusionCriteria |
| Details |
Patients who are below 18 years of age and admitted in CCU for less than 24 hours and who refuses to participate in study will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The need for mechanical ventilation/NIV/HFNC after extubation will depend on APACHE IV , SAPS III and SOFA scoring before extubation. |
After extubation and 24 hour after extubation of intubated patients in critical care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of ventilator free days will be inversely proportional to APACHE IV , SAPS III & SOFA score while ICU & hospital length of stay , ICU & hospital mortality & Reintubation rate will depend directly on APACHE IV , SAPS III & SOFA score. |
After 15 amd 30 days extubation of intubated patients in critical care unit. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/04/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Severe critically ill patients get admitted to different Intensive Care Units (ICUs) levels due to several causes, from medical to surgical branches. These scoring systems help standardise study research and compare the ICU’s outcome and care globally. The acute Physiology and Chronic Health Evaluation (APACHE) and simplified Acute Physiology Score (SAPS 3) scores have been most commonly used in the last 30 years. There is not a well-established system to predict the need for this artificial respiratory support, and thus, we are conducting this study to establish a relationship between severity scoring systems and the need for post-extubation artificial respiratory support. A study that establishes the relationship between these scoring systems and the need for post-extubation respiratory support needs to be done to stratify the risks before extubation and prepare the appropriate instrument. |