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

Phase 3

Not yet recruiting

Conditions: Acute respiratory failure,

Registration Number: CTRI/2024/01/061175

Lead Sponsor: JIPMER

Brief Summary: Mechanical ventilation is frequently required in patients with acute respiratory failure, even though being life saving, positive pressure ventilation has many detrimental effects like adverse effects on hemodynamics and ventilator induced lung injury (VILI). Lung protective ventilation which includes avoiding high tidal volume, high inspiratory pressures along with optimal positive end expiratory pressure (PEEP) selection is being followed to prevent VILI and improve oxygenation in patients with Acute Respiratory Distress Syndrome (ARDS). The optimal PEEP selection remains a difficult task even though a standardized approach to adjust PEEP is available in terms of PEEP/ FiO2 table as per ARDS network guidelines, and other PEEP titration methods guided by lung mechanics. These methods probably consider the global lung mechanics, and do not take into consideration the regional lung ventilation with varying PEEP levels. Prone ventilation is another ventilatory strategy in ARDS, where it is used as rescue therapy in severe ARDS, by which it helps in homogenisation of ventral- dorsal transpulmonary pressure difference, reduces dorsal lung compression and improves oxygenation. Moreover the effect on regional ventilation in use of optimal PEEP ventilation strategy in supine position when compared to prone ventilation is not well explored.

PEEP selection and titration are usually performed by assessing lung mechanics, and variables of lung mechanics are assessed considering the lung as a single unit, hence, the effects on regional lung ventilation are not apparent. Electrical impedance tomography is a non invasive, non-radioactive, bedside imaging tool, providing functional images with a high temporal resolution. Images obtained are also dynamic, allowing us to follow the response of the lungs to any therapeutic intervention. Regional overdistension and alveolar collapse can be visualized using EIT. Hence, it can be used to assess the status of regional lung ventilation with optimal PEEP ventilation as well as prone ventilation. As the regional lung ventilation in terms of regional overdistension and alveolar collapse can be visualized dynamically breath by breath using EIT, the effect of Optimal PEEP ventilation after PEEP titration and the effect of prone position ventilation on regional ventilation can be assessed in better certainty with EIT. By ventilating patients with Optimal PEEP, as identified by PEEP titration method, the regional lung ventilation achieved may be comparable to regional lung ventilation achieved by prone ventilation in patients with ARDS.

If comparable results are found, Optimal PEEP ventilation with PEEP titration can be used instead of Prone ventilation strategy.

Study Hypothesis : Regional lung ventilation (TIV dorsal /TIV total) between Optimal PEEP ventilation method and Prone position ventilation are comparable.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 48

Inclusion Criteria

75 years 2.Diagnosis of ARDS according to Berlinâ€™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 < 300 while on PEEP > 5 cm H2O d.Not fully attributed to cardiac failure and / or volume overload 3.PaO2/FiO2 <200 4.Anticipated duration of mechanical ventilation >48 hours.

Exclusion Criteria

1.Contraindication for prone positioning 2.Hemodynamic instability â€“ Requirement of two or more vasopressor infusions to maintain target MAP.
3.Already receiving prone ventilation 4.Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the changes in regional lung ventilation (TIV dorsal/TIVtotal) with optimal PEEP ventilation and Prone ventilation in patients with ARDS	1.Before intervention, \| 2.10 mins after intervention, \| 3. 6 hours after intervention \| 4. 12 hours after intervention.

Secondary Outcome Measures

Name	Time	Method
1)To compare the Driving Pressure between the groups.	2)To compare the changes in oxygenation from baseline (paO2/FiO2) between the groups.

Trial Locations

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Dr Allan Benhur C I
Principal investigator
8123621619
benhurallan@gmail.com