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

NCT ID: NCT05132933

Last Updated: 2024-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Shunt-group

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

Group Type EXPERIMENTAL

PEEP trial - Electrical Impedance Tomography

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Policlinico Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giacomo Grasselli

MD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giacomo Grasselli, Professor

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Locations

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Ospedale Maggiore Policlinico

Milan, MI, Italy

Site Status

Countries

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Italy

References

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Florio G, Zanella A, Slobod D, Guzzardella A, Protti I, Carlesso E, Canakoglu A, Fumagalli J, Scaravilli V, Colombo SM, Caccioppola A, Brioni M, Pesenti AM, Grasselli G. Impact of Positive End-Expiratory Pressure and FiO2 on Lung Mechanics and Intrapulmonary Shunt in Mechanically Ventilated Patients with ARDS Due to COVID-19 Pneumonia. J Intensive Care Med. 2024 May;39(5):420-428. doi: 10.1177/08850666231210485. Epub 2023 Nov 5.

Reference Type DERIVED
PMID: 37926984 (View on PubMed)

Other Identifiers

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COVID-19-SHUNT

Identifier Type: -

Identifier Source: org_study_id

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