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

Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure 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.

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: PEEP trial - Electrical Impedance Tomography

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milan, MI, Italy, 20122
      • Ospedale Maggiore Policlinico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shunt-group; Test of three different levels of positive end-expiratory pressure (PEEP)	Procedure: PEEP trial - Electrical Impedance Tomography; Three different levels of PEEP and two different levels of FiO2 will be tested without changing anything else in the baseline patient ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shunt at three different levels of positive end expiratory pressure (PEEP)	Shunt measured by arterial and mixed venous blood samples at each level of PEEP	30 minutes after change of positive end expiratory pressure (PEEP) level

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dead space at three different levels of positive end expiratory pressure (PEEP)	Dead space measured by capnography at each level of PEEP	30 minutes after change of positive end expiratory pressure (PEEP) level
Shunt and dead space at two different levels of inspiratory oxygen fraction for each level of positive end expiratory pressure (PEEP)	Shunt measured by arterial and mixed venous blood samples and dead space measured by capnography at each level of PEEP	30 minutes after change of positive end expiratory pressure (PEEP) level
Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT)	Ventilation/perfusion assessed by Electrical Impedance Tomography at each level of PEEP	30 minutes after change of positive end expiratory pressure (PEEP) level
Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)	Respiratory mechanics (including esophageal pressure measurement) assessed at each level of PEEP by performing end-inspiratory and end-expiratory pauses	30 minutes after change of positive end expiratory pressure (PEEP) level

Collaborators and Investigators

• Sponsor: Policlinico Hospital
• Investigators: Principal Investigator: Giacomo Grasselli, Professor, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Estimated): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: COVID-19-SHUNT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No