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

Primary Purpose

Respiratory Failure

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

PEEP trial - Electrical Impedance Tomography

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Ospedale Maggiore PoliclinicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shunt-group

Arm Description

Test of three different levels of positive end-expiratory pressure (PEEP)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Dead space measured by capnography at each level of PEEP

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

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

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

Full Information

NCT ID

NCT05132933

First Posted

November 23, 2021

Last Updated

November 23, 2021

Sponsor

Policlinico Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05132933

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Policlinico Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Shunt-group

Arm Type

Experimental

Arm Description

Test of three different levels of positive end-expiratory pressure (PEEP)

Intervention Type

Procedure

Intervention Name(s)

PEEP trial - Electrical Impedance Tomography

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Dead space measured by capnography at each level of PEEP

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Giacomo Grasselli, Professor

Phone

+ 39 02 55036708

giacomo.grasselli@unimi.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giacomo Grasselli, Professor

Organizational Affiliation

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale Maggiore Policlinico

City

Milan

State/Province

ZIP/Postal Code

20122

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gaicomo Grasselli, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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