Comparative study between two ventilatory methods on the changes in air distribution in different regions of the lung in patients with severe respiratory failure

Comparison of Optimal PEEP ventilation vs Prone position ventilation on changes in Regional Lung Ventilation in Patients with Acute Respiratory Distress Syndrome - A Randomized Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061175

Enrollment

Registered

2024-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J960- Acute respiratory failure

Interventions

Intervention1: Optimal PEEP ventilation: Patient will be sedated with IV Fentanyl and or Propofol and or Midazolam, according to hemodynamic status, and sedation will be titrated so that patient is no

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age :18 - 75 years 2. Diagnosis of ARDS according to Berlin’s criteria. a.Symptom begin within 1 week of insult, or new/worsening symptoms in last 1 week. b.Bilateral opacities on chest imaging c.PaO2/FiO2 5 cm H2O d.Not fully attributed to cardiac failure and / or volume overload 3.PaO2/FiO2 4.Anticipated duration of mechanical ventilation >48 hours

Exclusion criteria

Exclusion criteria: 1.Contraindication for prone positioning 2.Hemodynamic instability – Requirement of two or more vasopressor infusions to maintain target MAP. 3.Already receiving prone ventilation 4.Pregnancy

Design outcomes

Primary

Measure	Time frame
To compare the changes in regional lung ventilation (TIV dorsal/TIVtotal) with optimal PEEP ventilation and Prone ventilation in patients with ARDSTimepoint: 1.Before intervention, 2.10 mins after intervention, 3. 6 hours after intervention 4. 12 hours after intervention.	—

Secondary

Measure	Time frame
1)To compare the Driving Pressure between the groups. 2)To compare the changes in oxygenation from baseline (paO2/FiO2) between the groups. 3)To compare the changes in pCO2 level from baseline between the groups. 4)To compare the mean airway pressure between the groups. Timepoint: 1.Before intervention, 2.10 mins after intervention, 3. 6 hours after intervention 4. 12 hours after intervention.	—

Countries

India

Contacts

Public ContactALLAN BENHUR C I

JIPMER

p_kundra@hotmail.com9367602030

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026