| CTRI Number |
CTRI/2025/02/080965 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing RASI: A Simple Tool to Predict Intubation and Complications in Critically Ill Emergency Patients |
|
Scientific Title of Study
|
Evaluation of
Respiration adjusted shock index (RASI) as a predictor of endotracheal
intubation and peri-intubation complications in critically ill patients presenting
to Emergency department in a Tertiary care hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dipanjan Halder |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Trauma & Emergency Medicine, AIIMS Kalyani, Nadia
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL
741245
India |
| Phone |
8013422466 |
| Fax |
|
| Email |
dip2011halder@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dipanjan Halder |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Trauma & Emergency Medicine, AIIMS Kalyani, Nadia
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
WEST BENGAL
743122
India |
| Phone |
8013422466 |
| Fax |
|
| Email |
dip2011halder@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dipanjan Halder |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Kalyani |
| Address |
Department of Trauma & Emergency Medicine, AIIMS Kalyani, Nadia
Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL
743122
India |
| Phone |
8013422466 |
| Fax |
|
| Email |
dip2011halder@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Kalyani Saguna Basantapur NH 34 Connector, Nadia West Bengal 741245 |
|
|
Primary Sponsor
|
| Name |
Dipanjan Halder |
| Address |
Palta Kalyangram P.O Bengal Enamel North 24 Parganas 743122 |
| Type of Sponsor |
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 |
| Dr Dipanjan Halder |
Department of Trauma & Emergency Medicine, AIIMS Kalyani |
Trauma & Emergency Medicine ward, ground floor, IPD building, AIIMS Kalyani,Saguna, NH-34 Connector, Basantapur, Kalyani, West Bengal 741245
Nadia
WEST BENGAL |
8013422466
dip2011halder@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hemodynamic instability and triaged red for immediate need for treatment in emergency department and trauma patients triaged red according to trauma triage criteria
|
|
| ExclusionCriteria |
| Details |
1. Patients who are already intubated from outside
2. Patients prophylactically intubated for airway protection
3. Trauma patient requiring intubation for airway protection
4. Patients with burn injuries
5. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy (Area under curve) of RASI for impending endotracheal intubation |
within 24 hours of emergency admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the correlation between serum lactate & the incidence of intubation & peri-intubation complication
2. To evaluate the role of RASI as a predictor of peri-intubation complications
3. To evaluate the role of RASI in prognostication of critically ill patients
|
Death or at hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/03/2025 |
| 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
|
This study will evaluate the use of the Respiration Adjusted Shock Index (RASI) as a predictor of the need for endotracheal intubation and associated complications in critically ill patients in the emergency department. Patients with hemodynamic instability or those triaged as critical (red) based on WHO or trauma triage criteria will be monitored, assessed, and have RASI calculated if they meet the inclusion criteria. Blood tests, including lactate levels, will be analyzed, and patients will be followed to observe whether intubation is performed. If intubation occurs, the study will document the indications and complications such as peri-intubation hypotension, hypoxic episodes, cardiac arrest, and airway management challenges. Outcomes will be tracked until hospital discharge or mortality. |