| CTRI Number |
CTRI/2025/04/086036 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
"Studying how the amount of effort the ventilator uses to help a patient breathe affects the amount of oxygen getting to their brain in seriously ill patients on a breathing machine." |
|
Scientific Title of Study
|
To evaluate the relationship of mechanical power on the trend of cerebral oxygenation in critically ill patients on mechanical ventilation. A prospective observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chethan Hebbar K |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Raipur |
| Address |
Critical Care Unit, 2nd floor, Trauma and Emergency Block, Department of Anaesthesia and Critical Care, AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9481019468 |
| Fax |
|
| Email |
kchebbar5005@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chinmaya K Panda |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Critical Care Unit, 2nd Floor, Trauma and Emergency Block, Department of Anaesthesiology and Critical Care, AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
8098007711 |
| Fax |
|
| Email |
chinmaya.panda06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chethan Hebbar K |
| Designation |
Senior Resident |
| Affiliation |
AIIMS Raipur |
| Address |
Critical Care Unit, 2nd floor, Trauma and Emergency Block, Department of Anaesthesia and Critical Care, AIIMS Raipur.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9481019468 |
| Fax |
|
| Email |
kchebbar5005@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Raipur, Tatiband, Raipur, 492099 |
|
|
Primary Sponsor
|
| Name |
AIIMS Raipur |
| Address |
AIIMS Raipur, Tatiband, Raipur 492099 |
| 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 |
| Chethan Hebbar K |
AIIMS Raipur |
AIIMS Raipur, Tatiband, Raipur, 492099
Raipur
CHHATTISGARH |
9481019468
kchebbar5005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethic Committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years admitted to ICU requiring mechanical ventilation for more than 24 hours. |
|
| ExclusionCriteria |
| Details |
Pregancy
Less than 18 years
Head injury patients
Patients with raised ICP features
Patients with expected mechanical ventilation requirement of less than 24 hours
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the relationship of mechanical power on the trend of cerebral oxygenation in critically ill patients on mechanical ventilation. |
Initial 24 hours of mechanical ventilation in ICU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the relation of Partial pressure of arterial oxygen (PaO2) with the mechanical power.
|
Initial 24 hours of mechanical ventilation in ICU |
To evaluate the relation of Partial pressure of arterial carbon dioxide (PaCO2) with the mechanical power.
|
Initial 24 hours of mechanical ventilation in ICU |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
15/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/05/2025 |
| 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
|
Critically ill patients admitted for cardiorespiratory disorders require higher PEEP and PIP for adequate ventilation. Increased PEEP and PIP have been associated with reduced cerebral oxygenation. Both the PEEP and PIP are important components of Mechanical Power, and higher PEEP and PIP are associated with higher MP. Increased MP has shown deleterious effects on systemic oxygenation and cerebral perfusion in animal studies. There are no studies comparing the relationship of mechanical power on cerebral oxygenation in humans to our knowledge. Therefore, we plan to conduct a prospective observation study on the relationship of mechanical power on the trend of cerebral oxygenation in critically ill patients on mechanical ventilation. |