| CTRI Number |
CTRI/2025/07/090515 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of longer prone positioning on breathing and kidney health in ICU patients with severe lung injury
|
|
Scientific Title of Study
|
Utility of extended sessions of prone ventilation among prone ventilated ARDS (Acute Respiratory Distress Syndrome) patients in the reduction of pulmonary and renal inflammatory biomarkers and mortality outcomes – 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 |
Ms Shruthi |
| Designation |
PhD Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal Academy of Higher Education, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7026152286 |
| Fax |
|
| Email |
rshruthi822@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Souvik Chaudhuri |
| Designation |
Professor and Guide |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal Academy of Higher Education, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Souvik Chaudhuri |
| Designation |
Professor and Guide |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal Academy of Higher Education, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, MAHE, Manipal, Udupi, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Ms Shruthi |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, MAHE, Manipal, Karnataka 576104 |
| 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 |
| Ms Shruthi |
Kasturba Medical College Manipal |
Department of Critical Care, Kasturba Medical College, MAHE, Manipal, Karnataka 576104
Udupi
KARNATAKA |
7026152286
rshruthi822@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
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 |
(i) Adult patients of moderate-severe ARDS as per the New Global Definition of ARDS
(ii) Patients aged 18 years or above who are advised for prone position ventilation
(iii) ARDS patients with PaO2/FiO2 less than 150 with PEEP greater than 5 cmH2O with FiO2 of at least 0.6 and on invasive mechanical ventilation
|
|
| ExclusionCriteria |
| Details |
(i) Patients with a history of solid organ or bone marrow transplantation, who have been treated with chemotherapy for any type of malignancy, any biological agent, prednisone equivalent of more than 10 mg/day and 700 mg cumulative dose, antiproliferative agents and B-/T-cell depletion medications.
(ii) Pregnant patients
(iii) Patient with the history of Cardiac arrest
(iv) Patients referred for palliative care or discharged against medical advice.
(v) Patients diagnosed with chronic kidney disease (CKD)
(vi) Patients with penetrating chest injuries, pneumothorax at the time of recruitment.
(vii) Patients in the study arm who had to be turned to supine position before 24 hours of continuous prone position ventilation.
(viii) Patients who expire within 24 hours of prone position ventilation initiation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A reduction of at least 25% in the pulmonary and renal inflammatory biomarkers |
After 16-20 hours of Prone position ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Renal replacement therapy requirement |
28 days of ICU stay |
| Mortality |
28 days of ICU stay |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/08/2025 |
| 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="3"
Months="0"
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 is a prospective, observational, single-centre study conducted to evaluate the utility of extended prone ventilation sessions among patients with Acute Respiratory Distress Syndrome (ARDS). The study will include 45 adult ICU patients receiving prone ventilation as part of routine clinical management. The primary outcome is the reduction in pulmonary and renal inflammatory biomarker levels. Patients receiving standard care with prone ventilation will be observed at three time points: prior to initiation of prone positioning, after 16 hours of prone ventilation, and after 24 hours of prone ventilation. Biomarker levels will be compared across these intervals to assess the effect of extended prone positioning. The secondary outcome is all-cause in-hospital mortality, which will be analyzed to determine any association with duration of prone ventilation.
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