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Completed

NCT Number: NCT05132933

Gas Exchange Derangement Physiopathology in Critically Ill Patients With COVID-19

The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation

Exclusion criteria

  • Pregnancy
  • Hemodynamic instability (80-90 mmHg increase or 30-40 mmHg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmHg or electrocardiogram evidence of ischemia/arrhythmias)
  • Presence of pneumothorax and/or pneumomediastinum
  • Contraindications to Electrical Impedance Tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)

Treatment and study plan

PEEP trial - Electrical Impedance Tomography

Procedure

Three different levels of PEEP and two different levels of FiO2 will be tested without changing anything else in the baseline patient ventilation

Primary outcomes

  1. Shunt at three different levels of positive end expiratory pressure (PEEP)

    Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level

    Shunt measured by arterial and mixed venous blood samples at each level of PEEP

Secondary outcomes

  1. Dead space at three different levels of positive end expiratory pressure (PEEP)

    Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level

    Dead space measured by capnography at each level of PEEP

  2. Shunt and dead space at two different levels of inspiratory oxygen fraction for each level of positive end expiratory pressure (PEEP)

    Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level

    Shunt measured by arterial and mixed venous blood samples and dead space measured by capnography at each level of PEEP

  3. Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT)

    Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level

    Ventilation/perfusion assessed by Electrical Impedance Tomography at each level of PEEP

  4. Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)

    Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level

    Respiratory mechanics (including esophageal pressure measurement) assessed at each level of PEEP by performing end-inspiratory and end-expiratory pauses

Sponsors and collaborators

Lead sponsor

Policlinico Hospital

Other

Registry information

Official study title

Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2021
Registry last updated
Jan 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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