V/Q Matching in Pressure Support Ventilation

NCT ID: NCT05781802

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2024-01-01

Brief Summary

The aim of this study is to describe the effects of different levels of pressure support on ventilation-perfusion matching in patients recovering from ARDS, using electrical impedance tomography.

Detailed Description

Spontaneous breathing during mechanical ventilation has been attributed to both protective and negative effects on patient outcomes, largely varying based on the severity of lung injury. Indeed, in severe ARDS the avoidance of spontaneous efforts has an established protective role. However, spontaneous breathing promotes the distribution of tidal volume towards the dependent lung, and low levels of support pressure determine more homogeneous ventilation in patients recovering from ARDS, compared to higher support levels. Physiology supports the potential of spontaneous breathing to increase lung perfusion, through the decrease of intra-thoracic pressure leading to an increased venous return. This mechanism, in absence of right ventricular dysfunction, may lead to increased global lung perfusion. Furthermore, gas exchange improvements in experimental lung injury models during pressure support vs. controlled ventilation have been explained with redistribution of lung perfusion to nondependent lung areas and improvement of V/Q matching even in absence of significant lung recruitment.

Electrical impedance tomography has been clinically used as a non-invasive tool to assess V/Q matching in patients with ARDS and to compare V/Q matching prior to and after a cycle of prone position in spontaneously breathing patients with COVID-19.

The aim of this study is to describe the effects of different levels of pressure support on ventilation-perfusion matching in patients recovering from ARDS, using electrical impedance tomography.

Conditions

Acute Respiratory Failure; ARDS; Electrical Impedance Tomography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult mechanically ventilated patients with ARDS

Adult mechanically ventilated patients with ARDS (see inclusion/exclusion criteria)

Level of pressure support

Intervention Type: OTHER

Patients will be evaluated in two different conditions sequentially. The first condition will be at a clinically selected level of pressure support under stable clinical conditions.

This condition will be labeled according to P0.1:

• In case of P0.1<2, the clinically selected level of pressure support will be considered "High Pressure support".
• In case of P0.1>2, the clinically selected level of pressure support will be considered "Low Pressure support".

After data collection at clinically selected level of pressure support, pressure support level will be transiently increased or decreased (i.e. from high to low/ from low to high) to the lowest/highest clinically tolerated level, aiming at the predefined P01 thresholds, and then kept for 20 minutes under stable clinical conditions. Data collection will be repeated and then the clinically selected level of pressure support restored.

Interventions

Level of pressure support

Patients will be evaluated in two different conditions sequentially. The first condition will be at a clinically selected level of pressure support under stable clinical conditions.

This condition will be labeled according to P0.1:

• In case of P0.1<2, the clinically selected level of pressure support will be considered "High Pressure support".
• In case of P0.1>2, the clinically selected level of pressure support will be considered "Low Pressure support".

After data collection at clinically selected level of pressure support, pressure support level will be transiently increased or decreased (i.e. from high to low/ from low to high) to the lowest/highest clinically tolerated level, aiming at the predefined P01 thresholds, and then kept for 20 minutes under stable clinical conditions. Data collection will be repeated and then the clinically selected level of pressure support restored.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Need for invasive mechanical ventilation and ICU admission
• Diagnosis of ARDS at ICU admission or during ICU stay
• Informed consent
• Presence of central line in the internal jugular vein

Exclusion Criteria

• Any contraindication to Electrical impedance tomography monitoring (e. g. severe chest trauma or wounds)
• Cardiogenic pulmonary edema
• Pulmonary embolism
• Chronic obstructive pulmonary disease
• Pulmonary fibrosis
• Asthma exacerbation
• Pneumothorax and/or chest drainages
• Pre-existing diaphragmatic function impairment
• Neuro-muscular disease or impairment
• Moribund patients with limitation of care or expected survival <48h according to the treating physician

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

OTHER

Sponsor Role: lead

Responsible Party

Andrea Cortegiani, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo

Palermo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mariachiara ippolito, MD

Role: CONTACT

ippolito.mariachiara@gmail.com

00390916552700

Andrea Cortegiani, MD

Role: CONTACT

Facility Contacts

Mariachiara Ippolito, MD

Role: primary

References

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Reference Type: BACKGROUND

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Other Identifiers

EIT01

Identifier Type: -

Identifier Source: org_study_id