| CTRI Number |
CTRI/2026/04/108987 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Optimal proning duration in patients with moderate to severe acute respiratory distress syndrome |
|
Scientific Title of Study
|
A prospective observational study to find the optimal proning duration in patients with moderate to severe acute respiratory distress syndrome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumit Kumar Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Jodhpur |
| Address |
AICU, 3rd floor, department of anaesthesiology and critical care, AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9538776053 |
| Fax |
|
| Email |
sumitsinghafmc1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pradeep Kumar Bhatia |
| Designation |
Professor and Head |
| Affiliation |
All India Institute Of Medical Sciences, Jodhpur |
| Address |
AICU, 3rd floor, department of anaesthesiology and critical care, AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9829159665 |
| Fax |
|
| Email |
pk_bhatia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumit Kumar Singh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Jodhpur |
| Address |
AICU, 3rd floor, department of anaesthesiology and critical care, AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9538776053 |
| Fax |
|
| Email |
sumitsinghafmc1234@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
AICU, 3rd floor, department of Anaesthesiology and critical care, AIIMS, Basni, Jodhpur,Rajasthan,India 342005 |
| 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 Sumit Kumar Singh |
All India Institute Of Medical Sciences, Jodhpur |
AICU, 3rd floor, department of anaesthesiology and critical care, AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN |
9538776053
sumitsinghafmc1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
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.Age of more than 18 years
2. ARDS patients as defined by American European Consensus Conference
3. Endotracheal Intubation or Tracheostomised patients requiring Mechanical Ventilation |
|
| ExclusionCriteria |
| Details |
Severe hemodyanamic instability requiring high vasopressors that is requirement of 2 or more vasopressors to maintain MAP more than 65, Raised intracranial pressures, Cervical spine instability, Facial trauma, Known respiratory pathology. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the optimal duration of proning for maximum benefit in terms of improvement in P/F ratios more than 200 sustained for 8 hours in supine position after prone ventilation in patients with moderate to severe ARDS. |
Till P/F ratio improves to more than 200 for 8 hours after proning session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mortality rate at 30 days
2.Complication/ events(at different time intervals) during prone ventilation such as pressure sores, excidental extubation, ETT obstruction, hemoptysis, desaturation to less than 85%, hemodyanamic instability, cardiac arrest
3.Length of stay in ICU in surviving patients.
4.Respiratory mechanics(compliance) at various time intervals
5.Reinitiation of proning after termination
6.Duration of proning beyond which there is no further improvement in proning |
Till P/F ratio improves to more than 200 for 8 hours after proning session |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/05/2026 |
| 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
|
Acute Respiratory Distress Syndrome (ARDS) is a critical condition marked by acute onset of respiratory failure and widespread inflammation in the lungs.Despite extensive research and recent advances, ARDS is still associated with high morbidity and mortality rates (30-50%). Prone positioning has emerged as a promising intervention, shown to improve oxygenation and reduce mortality in severe ARDS when applied early and continuously.Prone positioning facilitates better alveolar ventilation and reduces the risk of ventilator-induced lung injury by promoting more uniform stress distribution across the lung tissues. The gravitational gradient in pleural pressure is more evenly distributed in the prone position compared to supine, enhancing ventilation distribution in the lung’s dorsal areas, which are often severely affected in ARDS. Duration of prone positioning is an important determinant of its effectiveness, as may the interval between the onset of ARDS and its application. Recent literature suggests that early and prolonged prone positioning can potentially decrease mortality in severe ARDS by reducing ventilator-induced lung injury and multisystem organ failure. However, inconsistencies in existing studies, due to variations in patient populations, proning duration and sessions, necessitate further investigation. Moreover, continuation of proning may cause improvement in lung oxygenation only upto a particular duration, following which the further sessions of proning may not provide any additional benefit. Also, there has not been much research done to assess the optimal duration of proning that would provide the maximum benefit in lung mechanics. Hence, an appropriately powered study is needed to re-evaluate the duration and sessions of prone ventilation that is required to provide maximum improvement in oxygenation and reduce mortality in patients with ARDS. Research question: Does the benefits of prone ventilation on lung mechanics in patients with moderate to severe Acute Respiratory Distress Syndrome plateaus after 4 sessions of proning of 16h per day. |