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

• Sponsor: Policlinico Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05132933
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 14.9
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Procedure: PEEP trial - Electrical Impedance Tomography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Maggiore Policlinico	Milan	MI	Italy	20122

Sponsors and Collaborators

• Policlinico Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Giacomo Grasselli, MD, Professor, Policlinico Hospital
• ClinicalTrials.gov Identifier: NCT05132933
• Other Study ID Numbers: COVID-19-SHUNT
• First Posted: Nov 24, 2021
• Last Update Posted: Nov 24, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Insufficiency

Study Results

No Results Posted as of Nov 24, 2021