Respiratory FailureNCT05132933
Gas Exchange Derangement Physiopathology in Critically Ill Patients With COVID-19
A study testing PEEP trial - Electrical Impedance Tomography in people with Respiratory Failure, run by Policlinico Hospital at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- PEEP trial - Electrical Impedance Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19
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.
- Conditions
- Respiratory Failure
- Being tested
- PEEP trial - Electrical Impedance Tomography
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP trial - Electrical Impedance TomographyProcedure or surgery
Three different levels of PEEP and two different levels of FiO2 will be tested without changing anything else in the baseline patient ventilation
| Study group | Role | What they receive |
|---|---|---|
| Shunt-group | Experimental | Test of three different levels of positive end-expiratory pressure (PEEP) Receives: Procedure: PEEP trial - Electrical Impedance Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Dead space measured by capnography at each level of PEEP
Measured: 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)
Shunt measured by arterial and mixed venous blood samples and dead space measured by capnography at each level of PEEP
Measured: 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)
Ventilation/perfusion assessed by Electrical Impedance Tomography at each level of PEEP
Measured: 30 minutes after change of positive end expiratory pressure (PEEP) level
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
Measured: 30 minutes after change of positive end expiratory pressure (PEEP) level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Oct 2021
- Primary completion30 Jun 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giacomo Grasselli, Policlinico Hospital
- Investigators
- Giacomo Grasselli, Professor, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132933
- Sponsor's protocol ID
- COVID-19-SHUNT
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37926984
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Exchange Derangement Physiopathology and Response to Different Levels of Positive End-expiratory Pressure in Critically Ill Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05132933
- Acronym / sponsor ID
- COVID-19-SHUNT
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shunt-group | Experimental | Procedure: PEEP trial - Electrical Impedance TomographyTest of three different levels of positive end-expiratory pressure (PEEP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted in intensive care unit for COVID-19 related Acute Respiratory Distress Syndrome (ARDS) requiring invasive mechanical ventilation
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEEP trial - Electrical Impedance TomographyThree different levels of PEEP and two different levels of FiO2 will be tested without changing anything else in the baseline patient ventilation | Procedure or surgery | Shunt-group |
Primary outcome
Shunt at three different levels of positive end expiratory pressure (PEEP)
Time frame: 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
4 secondary outcomes
Dead space at three different levels of positive end expiratory pressure (PEEP)
Time frame: 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)
Time frame: 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)
Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level
Respiratory mechanics at three different levels of positive end expiratory pressure (PEEP)
Time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Derived from this study: PubMed 37926984Florio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giacomo Grasselli, Professor principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP trial - Electrical Impedance Tomography in people with Respiratory Failure, run by Policlinico Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shunt at three different levels of positive end expiratory pressure (PEEP) (time frame: 30 minutes after change of positive end expiratory pressure (PEEP) level). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05132933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.