Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.

ARDS, Human Clinical Trial

Official title:

Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients..

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05337059
• Other study ID #: 2019-A03242-55
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2022
• Est. completion date: April 2024

Study information

• Verified date: April 2022
• Source: University Hospital, Angers
• Contact: Francois Beloncle, MD-PhD
• Phone: +33 2 41 35 58 65
• Email: francois.beloncle[@]univ-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Description:

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older

• Moderate to severe ARDS

• Written informed consent obtained from patient' surrogates

Exclusion Criteria:

• Pneumothorax

• Known pregnancy

• Contraindication to electrical impedance tomography or esophageal pressure measurements

Related Conditions & MeSH terms

• ARDS, Human
• Respiratory Distress Syndrome

Intervention

Other:
• PEEP and Tidal Volume Titration
PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures

Locations

Country	Name	City	State
France	Chu Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation strategy failure	Number of patients with failure criteria (barotrauma, hemodynamic failure, rescue therapy or acidemia)	48 hours
Secondary	Short term physiologicals effects on hemodynamics	Cardiac index assed by Echocardiography (L/min/m^2)	45 minutes
Secondary	All-cause mortality at day 28	All-cause mortality	28 days
Secondary	Ventilator-free days at day 28	Number of alive ventilator free days	28 days
Secondary	Short term physiologicals effects on respiratory mechanics	recruited lung volume (mL)	45 minutes
Secondary	Short term physiologicals effects on gas exchange	PaO2/FiO2 ratio (mmHg)	45 minutes
Secondary	Short term physiologicals effects on gas exchange	VD/VT	45 minutes
Secondary	Short term physiologicals effects on gas exchange	PaCO2 (mmHg)	45 minutes
Secondary	Short term physiologicals effects on respiratory mechanics	distribution of ventilation assed by electrical impedance tomography (COV, %)	45 minutes