Severe PneumoniaNCT07112976
Lung Response to a Higher PEEP During Severe Pneumonia: a CT Study
An observational study of Severe Pneumonia, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
At their institution, the investigators routinely assess the individual response of mechanically ventilated patients with acute respiratory failure to higher positive end-expiratory pressure (PEEP) by examining changes in lung aeration through lung computed tomography (CT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Pneumonia
- How many people
- 47 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Adults admitted to the ICU with severe pneumonia, treated with mechanical ventilation
Who may be able to join
- adult (≥18 years of age) patients
- admitted to ICU from 1/10/2022 to 31/12/2024
- with severe pneumonia
- treated with mechanical ventilation
- who underwent the two lung CTs at 10 and 15 cmH2O
Who cannot join
- pneumothorax
- pneumomediastinum
- lung CT was obtained with contrast medium to rule out pulmonary embolism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Higher Positive End-expiratory Pressure (PEEP) on Lung Hyperinflation and Collapse in Patients With Severe Pneumonia: a Computed Tomography Study
At their institution, the investigators routinely assess the individual response of mechanically ventilated patients with acute respiratory failure to higher positive end-expiratory pressure (PEEP) by examining changes in lung aeration through lung computed tomography (CT). They typically obtain two lung CT scans during an end-expiratory hold, one at a PEEP of 10 cmH2O and another at 15 cmH2O. Recruitment and hyperinflation are measured by assessing the decrease in the volume of non-aerated lung regions (with a density greater than -100 HU) and the increase in the volume of hyperinflated lung regions (with a density of less than -900 HU) between the two CT scans. If recruitment exceeds hyperinflation, the response to higher PEEP is considered "positive", and medical doctors are encouraged to treat that patient with a higher PEEP. Conversely, if hyperinflation exceeds recruitment, the response is deemed "negative", and a higher PEEP is discouraged. This assessment is further complemented by a "PEEP test," during which gas exchange (specifically arterial oxygen and carbon dioxide tension) and respiratory system mechanics (including compliance) are evaluated while ventilating with PEEP levels of 10 and 15 cmH2O.
In this retrospective analysis, the investigators will focus on patients with severe pneumonia who underwent the two lung CTs as part of their routine clinical practice. They will retrieve data on primary demographic characteristics, significant comorbidities, causes of pneumonia, severity of acute illness, and treatments delivered. Additionally, they will review the results of the quantitative analysis of the lung CT scans taken at 10 and 15 cmH2O, and the PEEP tests. The primary aim of this study is to determine the proportion of patients with net hyperinflation in response to higher PEEP.
- Conditions
- Severe Pneumonia
- Keywords
- Mechanical ventilation, Positive end-expiratory pressure, Hyperinflation, Recruitment, Computed tomography
- Medical subject headings
- Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung response to a higher PEEP
The primary study objective is to evaluate the effects of higher PEEP with quantitative analysis of lung CT scans in patients with severe pneumonia. We hypothesize that 50% of these patients will exhibit more hyperinflation than recruitment.
We measure recruitment and hyperinflation by assessing the change in the volume of non-aerated lung regions (with a density greater than -100 HU) and hyperinflated lung regions (with a density of less than -900 HU) between the two CT scans.
Measured: The effects of a higher PEEP will be assessed by comparing the CT scans taken at ICU admission, with a PEEP of 10 or 15 cmH2O, within the same subject. Usually, the interval between the two CT scans is a few minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Oct 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Severe PneumoniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112976
- Sponsor's protocol ID
- Studio retrospettivo n. 28/25
- Status last verified
- Aug 2025
- First submitted
- 3 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Protti A, Santini A, Pennati F, Chiurazzi C, Cressoni M, Ferrari M, Iapichino GE, Carenzo L, Lanza E, Picardo G, Caironi P, Aliverti A, Cecconi M. Lung Response to a Higher Positive End-Expiratory Pressure in Mechanically Ventilated Patients With COVID-19. Chest. 2022 Apr;161(4):979-988. doi: 10.1016/j.chest.2021.10.012. Epub 2021 Oct 16.
PubMed 34666011
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Higher Positive End-expiratory Pressure (PEEP) on Lung Hyperinflation and Collapse in Patients With Severe Pneumonia: a Computed Tomography Study
- ClinicalTrials.gov ID
- NCT07112976
- Acronym / sponsor ID
- Studio retrospettivo n. 28/25
- Conditions
- Severe Pneumonia
- Keywords
- Mechanical ventilation, Positive end-expiratory pressure, Hyperinflation, Recruitment, Computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 8 Aug 2025 (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.
At their institution, the investigators routinely assess the individual response of mechanically ventilated patients with acute respiratory failure to higher positive end-expiratory pressure (PEEP) by examining changes in lung aeration through lung computed tomography (CT). They typically obtain two lung CT scans during an end-expiratory hold, one at a PEEP of 10 cmH2O and another at 15 cmH2O. Recruitment and hyperinflation are measured by assessing the decrease in the volume of non-aerated lung regions (with a density greater than -100 HU) and the increase in the volume of hyperinflated lung regions (with a density of less than -900 HU) between the two CT scans. If recruitment exceeds hyperinflation, the response to higher PEEP is considered "positive", and medical doctors are encouraged to treat that patient with a higher PEEP. Conversely, if hyperinflation exceeds recruitment, the response is deemed "negative", and a higher PEEP is discouraged. This assessment is further complemented by a "PEEP test," during which gas exchange (specifically arterial oxygen and carbon dioxide tension) and respiratory system mechanics (including compliance) are evaluated while ventilating with PEEP levels of 10 and 15 cmH2O.
In this retrospective analysis, the investigators will focus on patients with severe pneumonia who underwent the two lung CTs as part of their routine clinical practice. They will retrieve data on primary demographic characteristics, significant comorbidities, causes of pneumonia, severity of acute illness, and treatments delivered. Additionally, they will review the results of the quantitative analysis of the lung CT scans taken at 10 and 15 cmH2O, and the PEEP tests. The primary aim of this study is to determine the proportion of patients with net hyperinflation in response to higher PEEP.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the ICU with severe pneumonia, treated with mechanical ventilation
Key inclusion criteria (5 listed)
- adult (≥18 years of age) patients
- admitted to ICU from 1/10/2022 to 31/12/2024
- with severe pneumonia
- treated with mechanical ventilation
- who underwent the two lung CTs at 10 and 15 cmH2O
Key exclusion criteria (3 listed)
- pneumothorax
- pneumomediastinum
- lung CT was obtained with contrast medium to rule out pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lung response to a higher PEEP
Time frame: The effects of a higher PEEP will be assessed by comparing the CT scans taken at ICU admission, with a PEEP of 10 or 15 cmH2O, within the same subject. Usually, the interval between the two CT scans is a few minutes.
The primary study objective is to evaluate the effects of higher PEEP with quantitative analysis of lung CT scans in patients with severe pneumonia. We hypothesize that 50% of these patients will exhibit more hyperinflation than recruitment. We measure recruitment and hyperinflation by assessing the change in the volume of non-aerated lung regions (with a density greater than -100 HU) and hyperinflated lung regions (with a density of less than -900 HU) between the two CT scans.
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 13 Aug 2025.
- Background: PubMed 34666011Protti A, Santini A, Pennati F, Chiurazzi C, Cressoni M, Ferrari M, Iapichino GE, Carenzo L, Lanza E, Picardo G, Caironi P, Aliverti A, Cecconi M. Lung Response to a Higher Positive End-Expiratory Pressure in Mechanically Ventilated Patients With COVID-19. Chest. 2022 Apr;161(4):979-988. doi: 10.1016/j.chest.2021.10.012. Epub 2021 Oct 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Pneumonia, run by Istituto Clinico Humanitas 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 5 inclusion and 3 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 13 Aug 2025. 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?
Lung response to a higher PEEP (time frame: The effects of a higher PEEP will be assessed by comparing the CT scans taken at ICU admission, with a PEEP of 10 or 15 cmH2O, within the same subject. Usually, the interval between the two CT scans is a few minutes.). 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 NCT07112976, 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 13 Aug 2025.