Effects of Ventilation With Tidal Volume Adjusted on Driving Pressure on Ventilation/Perfusion Ratios and Hemodynamics in ARDS

NCT06817629 | Not Yet Recruiting

• 1 other identifier: APHP241429
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The driving pressure (DP) is defined as the pressure above the end-expiratory pressure (PEEP) required to distend the respiratory system by the tidal volume (Vt). It is calculated as follows: DP = Plateau pressure - PEEP. It is also equal to the ratio between the tidal volume and the compliance of the respiratory system (Crs): DP = Vt/Crs. Crs is correlated with end-expiratory lung volume, i.e., the lung volume available to receive the tidal volume. DP allows adaptation of the Vt to the available lung volume when the lungs are diseased, rather than to a fraction of lung size when they are healthy, as occurs when tidal volume is adjusted in mL/kg of predicted body weight (PBW). DP is therefore a better reflection of the deformation applied by the tidal volume and the risk of overdistension. It is an important prognostic indicator in acute respiratory distress syndrome (ARDS), with a risk of excess mortality when DP exceeds 14 cm H2O. Conversely, an excessively low DP, suggesting a low tidal volume in relation to the available lung volume, may theoretically also be accompanied by deleterious effects: de-recruitment, atelectrauma, the need to increase respiratory rate, the need for significant sedation, or even curarization. DP and Vt can influence hemodynamics, as overdistension is associated with an increase in dead space and the occurrence of acute cor pulmonale. On the other hand, de-recruitment due to low tidal volume can lead to hypoxic vasoconstriction with an increase in right ventricular afterload.

Conditions

ARDS

Keywords

ARDS; V/Q ratios; Hemodynamic

Outcome Measures

Primary Outcomes (1)

• distribution of perfusion and ventilation across VA/Q ratios zones, wasted ventilation and perfusion.

  demonstration that ventilate patient with ARDS with an objective of protective driving pressure vent may change VA/Q ratio by using electrical impedance tomography

  24 hours

Secondary Outcomes (2)

• DP-vent may induce a modification in patient with right ventricular

  24 hours

• Change in right ventricular systolic function parameters

  24 hours

Interventions

Effects of ventilation with tidal volume adjusted on driving pressure on ventilation/perfusion ratios and hemodynamics in ARDS OTHER

To ventilated patients with ARDS with an objective of driving pressure than a tidal volume set on predicted body weight

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with ARDS under deep sedation +/- paralized

You may qualify if:

• Age ≥ 18 years
• ARDS moderate to severe according to the Berlin criteria
• Patient receiving continuous sedation and curarization
• Free and informed consent from the patient or family member

You may not qualify if:

• Pregnancy
• Adult patient subject to a legal protection measure (tutor, curator, etc.)
• Patients with a pacemaker, automatic implantable cardioverter defibrillator,
• Contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
• Undrained pneumothorax, bronchopleural fistula
• Hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR

Créteil, 94010, France

Location

MeSH Terms

Interventions

Hemodynamics

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Pascale LABEDADE, PhD

CONTACT

+33145178506; Pascale.labedade@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: February 10, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): April 2, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)