Clinical trial NCT05583461: Ventilator-induced Right Ventricular Injury During EIT-based PEEP Titration in Patients With ARDS
Official title: Ventilator-induced Right Ventricular Injury During Electrical Impedance Tomography-based Positive End-expiratory Pressure Titration in Patients With Acute Respiratory Distress Syndrome: a Pilot Physiological Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: DIAGNOSTIC

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.

Detailed description: Acute respiratory distress syndrome (ARDS) is a diffuse pulmonary inflammatory disease with multifactorial etiology that is very common in patients admitted to the intensive care unit (ICU) and is associated with unsatisfactory short- and long-term prognosis. Patients with ARDS can develop right ventricular (RV) failure, which occurs in 22-50% of patients despite lung protective ventilation and is associated with increased mortality. Despite being required to ensure survival of patients with ARDS, mechanical ventilation itself may have injurious effects on RV function. First, high transpulmonary pressure, secondary to the use of high tidal volume, plateau pressure or positive end-expiratory pressure (PEEP), can cause alveolar overdistension, especially in the aerated parenchymal regions, and collapse of alveolar vessels. The consequent increase in pulmonary arterial pressure may lead to excessively high RV afterload and reduced systolic function. Second, the development of parenchymal atelectasis potentially secondary to the application of low tidal volumes and/or PEEP may increase pulmonary vascular resistance because of extra-alveolar vascular collapse. Finally, mechanical ventilation can have indirect effects on pulmonary circulation and RV function, mediated by alveolar oxygenation, acidosis, and hypercapnia.

The application of PEEP can prevent cyclic opening and closing of the alveoli (i.e., atelectrauma) and improve oxygenation. Ideally, PEEP should maintain lung recruitment and optimize oxygenation and dead space, while at the same time avoiding alveolar overdistension and hemodynamic complications. However, the PEEP titration strategy in patients with ARDS is still widely debated, due to the variability of the effects of PEEP in different patients and different lung parenchymal regions in the same patient. Depending on the extent of potentially recruitable lung parenchyma and the distribution of lung damage, the application of PEEP can cause alveolar overdistension and promote RV failure and/or favor alveolar recruitment and improve RV function. Therefore, it is stil unclear what level of PEEP is associated with the optimization of RV function in patients with ARDS. We may hypothesize that the level of PEEP able to reduce alveolar collapse without increasing overdistension may improve RV function.

Several strategies have been suggested to assess lung recruitability and PEEP responsiveness in patients with ARDS. Electrical impedance tomography (EIT) is a bedside non-invasive technique that monitors the regional distribution of lung ventilation. The choice of the PEEP value that minimizes the extent of overdistension and atelectasis, as assessed with EIT, was associated with better respiratory mechanics and survival in patients with severe ARDS in some pilot studies.

The aim of this prospective pathophysiological interventional study is to evaluate the variation of RV size and function with transthoracic echocardiography in adult patients requiring invasive controlled mechanical ventilation for moderate-to-severe ARDS with four different PEEP values applied according to a randomized sequence in each patient:

* The level of PEEP determined according to the ARDS Network low PEEP-fraction of inspired oxygen (FiO2) table;
* The PEEP value that minimizes the risk of overdistension and atelectasis, as determined by EIT;
* The highest PEEP value that minimizes the risk of overdistension, as determined by EIT;
* The lowest PEEP level that minimizes the risk of atelectasis, as determined by EIT.

The primary hypothesis of the study is that the level of PEEP that simultaneously minimizes alveolar overdistension and collapse is associated with better RV function than the PEEP level selected based on the low PEEP-FiO2 table and PEEP levels that minimize overdistension and collapse, separately. The secondary hypotheses of the study are that: 1) the level of PEEP that minimizes overdistension is associated with better RV function than the level of PEEP that minimizes collapse; 2) the PEEP level that minimizes alveolar collapse is associated with greater pulmonary air content, as assessed by lung ultrasound, compared to the PEEP levels chosen based on the low PEEP-FiO2 table, the PEEP level that minimizes overdistension and collapse simultaneously, and the PEEP level that minimizes overdistension.

The physiological data obtained from this study may offer valuable insights into the right ventricular-protective level of PEEP in patients with ARDS and support future large randomized studies investigating PEEP levels associated with improved patient survival.

Eligibility criteria: Inclusion criteria:

1. Moderate to severe acute respiratory distress syndrome
2. Inclusion within 72 hours of acute respiratory distress syndrome diagnosis
3. Endotracheal intubation or tracheostomy

Exclusion criteria:

1. Age lower than 18 years old
2. Pregnancy
3. Absence of informed consent
4. Thoracic surgery or lung transplant during the admission
5. 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)
6. 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)

Primary outcomes:
measure: Right ventricle diameter 1
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricle diameter 2
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricle fractional area change
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Eccentricity index
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Tricuspid annular plane systolic excursion
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Systolic velocity of the lateral tricuspid annulus derived from tissue Doppler imaging
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricular index of myocardial performance
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricle systolic pressure
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Myocardial isovolumic acceleration
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricle stroke index
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricle stroke work index
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Right ventricular free wall longitudinal strain
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
Secondary outcomes:
measure: Ventilator settings
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Respiratory mechanics
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Arterial blood gas analysis
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Dead space
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Ventilatory ratio
timeFrame: Measured after 20 minutes from the application of each of the four levels of PEEP
measure: Shunt
timeFrame: Measured after 20 minutes from the application of the intervention
measure: Hemodynamics
timeFrame: Measured after 20 minutes from the application of the intervention
measure: Pleural and lung ultrasound
timeFrame: Measured after 20 minutes from the application of the intervention
measure: Renal ultrasound
timeFrame: Measured after 20 minutes from the application of the intervention
measure: Ultrasound image quality
timeFrame: Measured after 20 minutes from the application of the intervention
Other outcomes:
Locations:
city: Padua
country: Italy
facility: University Hospital of Padua
Study officials:
affiliation: Institute of Anesthesiology and Intensive Care, Padova University Hospital
name: Tommaso Pettenuzzo, MD
role: PRINCIPAL_INVESTIGATOR
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