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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05132933
• Other study ID #: COVID-19-SHUNT
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2021
• Source: Policlinico Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Maggiore Policlinico	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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