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

Not Applicable

Completed

• Conditions: Respiratory Failure
• Interventions: Procedure: PEEP trial - Electrical Impedance Tomography

• Registration Number: NCT05132933
• Lead Sponsor: Policlinico Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-11-23
• Study First Posted: 2021-11-24
• Primary Completion: 2022-06-30
• Study Completion: 2022-12-30
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Shunt-group	PEEP trial - Electrical Impedance Tomography	Test of three different levels of positive end-expiratory pressure (PEEP)

Primary Outcome Measures

Name	Time	Method
Shunt at three different levels of positive end expiratory pressure (PEEP)	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 Outcome Measures

Name	Time	Method
Ventilation/perfusion at three different levels of positive end expiratory pressure (PEEP) assessed by electrical impedance tomography (EIT)	30 minutes after change of positive end expiratory pressure (PEEP) level	Ventilation/perfusion assessed by Electrical Impedance Tomography at each level of PEEP
Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)	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
Dead space at three different levels of positive end expiratory pressure (PEEP)	30 minutes after change of positive end expiratory pressure (PEEP) level	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)	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

Trial Locations

Locations (1)

Ospedale Maggiore Policlinico; 🇮🇹 Milan, MI, Italy