NCT05132933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 25, 2024

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

November 23, 2021

Last Update Submit

January 24, 2024

Conditions

Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

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

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

  • 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

  • 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

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

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

Study Arms (1)

Shunt-group

EXPERIMENTAL

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

Procedure: PEEP trial - Electrical Impedance Tomography

Interventions

PEEP trial - Electrical Impedance TomographyPROCEDURE

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

Shunt-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Related Publications (1)

  • 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.

    PMID: 37926984DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Giacomo Grasselli, Professor

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

November 23, 2021

First Posted

November 24, 2021

Study Start

October 1, 2021

Primary Completion

June 30, 2022

Study Completion

December 30, 2022

Last Updated

January 25, 2024

Record last verified: 2021-11

Locations

IT(1)