Ventilator-induced Right Ventricular Injury During EIT-based PEEP Titration in Patients With ARDS

NCT05583461 | Unknown

• 1 other identifier: 5546/AO/22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Right ventricular failure may be associated with mortality in patients with acute respiratory distress syndrome (ARDS). Mechanical ventilation may promote right ventricular failure by inducing alveolar overdistention and atelectasis. Electrical impedance tomography (EIT) is a bedside non-invasive technique assessing the regional distribution of lung ventilation, thus helping titrating positive end-expiratory pressure (PEEP) to target the minimum levels of alveolar overdistension and atelectasis. The aim of this physiologic randomized crossover trial is to assess right ventricular size and function with transthoracic echocardiography with different levels of PEEP in adult patients with moderate-to-severe ARDS undergoing controlled invasive mechanical ventilation: the level of PEEP determined according to the ARDS Network low PEEP-FiO2 table, the PEEP value that minimizes the risk of alveolar overdistension and atelectasis (as determined by EIT), the highest PEEP value minimizing the risk of alveolar overdistension (as determined by EIT), and the lowest PEEP level that minimizes the risk of alveolar atelectasis (as determined by EIT). Our findings may offer valuable insights into the level of PEEP favoring right ventricular protection during mechanical ventilation in patients with ARDS.

Conditions

Acute Respiratory Distress Syndrome; Right Ventricular Dysfunction

Keywords

Acute respiratory distress syndrome; Mechanical ventilation; Right ventricular dysfunction; Positive end-expiratory pressure; Electrical impedance tomography; Echocardiography

Outcome Measures

Primary Outcomes (12)

• Right ventricle diameter 1

  Maximal transversal dimension in the basal one third of right ventricular inflow at end-diastole in the right ventricle-focused apical four-chamber view

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricle diameter 2

  Transversal right ventricular diameter in the middle third of right ventricular inflow, approximately halfway between the maximal basal diameter and the apex, at the level of papillary muscles at end-diastole.

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricle fractional area change

  Ratio of the difference between end-diastolic area and end-systolic area to end-diastolic area, which are determined after manual tracing of right ventricular endocardial border from the lateral tricuspid annulus along the free wall to the apex and back to medial tricuspid annulus, along the interventricular septum at end-diastole and at end-systole, in the right ventricle-focused apical four-chamber view

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Eccentricity index

  Ratio between two left ventricular axes, one parallel to the interventricular septum and one perpendicular to this, in the mid-papillary parasternal short axis view

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Tricuspid annular plane systolic excursion

  Tricuspid annular longitudinal excursion by M-mode, measured between end-diastole and peak systole in the apical four-chamber view that achieves parallel alignment of Doppler beam with right ventricular free wall longitudinal excursion

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Systolic velocity of the lateral tricuspid annulus derived from tissue Doppler imaging

  Peak systolic velocity of lateral tricuspid annulus by pulsed-wave tissue Doppler imaging in the apical four-chamber view that achieves parallel alignment of Doppler beam with right ventricular free wall longitudinal excursion

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricular index of myocardial performance

  The ratio of the sum between isovolumic contraction and relaxation times to ejection time measured by pulsed-wave tissue Doppler imaging in the apical four-chamber view that achieves parallel alignment of Doppler beam with right ventricular free wall longitudinal excursion

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricle systolic pressure

  Calculated from the velocity of tricuspid regurgitation jet, measured in the view allowing the highest value, by applying simplified Bernoulli equation and adding right atrial pressure estimated from central venous pressure

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Myocardial isovolumic acceleration

  Ratio of lateral tricuspid annulus peak velocity during isovolumic contraction to acceleration time by pulsed-wave tissue Doppler imaging in the apical four-chamber view that achieves parallel alignment of Doppler beam with right ventricular free wall longitudinal excursion

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricle stroke index

  Ratio of right ventricular stroke volume, calculated as product between velocity-time integral at the level of pulmonary valve and transverse area of right ventricular outflow tract in the aortic valve-level parasternal short axis view during systole, and body surface area

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricle stroke work index

  Product between right ventricle stroke index and right ventricle systolic pressure

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Right ventricular free wall longitudinal strain

  Peak value of longitudinal speckle-tracking-derived strain, averaged over the three segments of the right ventricular free wall, after manual tracing of right ventricular endocardial border from the lateral tricuspid annulus along the free wall to the apex and back to medial tricuspid annulus in right ventricle-focused apical four-chamber view

  Measured after 20 minutes from the application of each of the four levels of PEEP

Secondary Outcomes (10)

• Ventilator settings

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Respiratory mechanics

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Arterial blood gas analysis

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Dead space

  Measured after 20 minutes from the application of each of the four levels of PEEP

• Ventilatory ratio

  Measured after 20 minutes from the application of each of the four levels of PEEP

Study Arms (4)

PEEP level according to the low PEEP-FiO2 table

EXPERIMENTAL

Positive end-expiratory pressure (PEEP) level selected based on patient's fraction of inspired oxygen (FiO2) according to the low PEEP-FiO2 table proposed by the Acute Respiratory Distress Syndrome Network Guidelines

Procedure: Positive end-expiratory pressure titration

PEEP minimizing the risk of overdistension and atelectasis

EXPERIMENTAL

Positive end-expiratory pressure (PEEP) level selected based on the intersection between the curves of the cumulative percentages of compliance loss due to alveolar overdistension and atelectasis, respectively, as assessed with an electrical impedance tomography-based decremental PEEP trial

Procedure: Positive end-expiratory pressure titration

PEEP minimizing the risk of overdistension

EXPERIMENTAL

Highest positive end-expiratory pressure (PEEP) level associated with no alveolar overdistention selected based on the curve of the cumulative percentage of compliance loss due to alveolar overdistension, as assessed with an electrical impedance tomography-based decremental PEEP trial

Procedure: Positive end-expiratory pressure titration

PEEP minimizing the risk of atelectasis

EXPERIMENTAL

Lowest positive end-expiratory pressure (PEEP) level associated with no alveolar collapse selected based on the curve of the cumulative percentage of compliance loss due to alveolar collapse, as assessed with an electrical impedance tomography-based decremental PEEP trial

Procedure: Positive end-expiratory pressure titration

Interventions

Positive end-expiratory pressure titration PROCEDURE

Positive end-expiratory pressure level

PEEP level according to the low PEEP-FiO2 table; PEEP minimizing the risk of atelectasis; PEEP minimizing the risk of overdistension; PEEP minimizing the risk of overdistension and atelectasis

Eligibility Criteria

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

You may qualify if:

• Moderate to severe acute respiratory distress syndrome
• Endotracheal intubation or tracheostomy

You may not qualify if:

• Age lower than 18 years old
• Pregnancy
• Absence of informed consent
• Thoracic surgery or lung transplant during the admission
• Contraindications to recruitment maneuvers (mean arterial pressure lower than 65 mmHg despite administration of fluids or vasopressors, active air leaks through a chest tube, pneumothorax or subcutaneous or mediastinal emphysema in absence of chest drainage)
• Contraindications to electrical impedance tomography (contraindication to recruitment maneuvers, presence of pacemakers or other electronic devices in the chest, injuries or burns in the electrode placement area)

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

University Hospital of Padua

Padua, Italy

RECRUITING

Related Publications (43)

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  BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Tommaso Pettenuzzo, MD

  Institute of Anesthesiology and Intensive Care, Padova University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tommaso Pettenuzzo, MD

CONTACT

00390498213090; tommaso.pettenuzzo@aopd.veneto.it

Vincenzo Mastronardo

CONTACT

00390498213090; vincenzo.mastronardo@aopd.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Being sedated and paralyzed, included patients will not be aware of the study phase. The investigators performing the echocardiographic exams will be blinded to the experimental setting because the PEEP level set at the ventilator will be covered. The echocardiographic measurement will be performed offline with no information on the experimental settings.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Randomized sequence of application of four levels of positive end-expiratory pressure in adult patients requiring invasive controlled mechanical ventilation for acute respiratory distress syndrome

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: October 26, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)