NCT07112976

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

2.3 years

First QC Date

July 3, 2025

Last Update Submit

August 8, 2025

Conditions

Keywords

Mechanical ventilationPositive end-expiratory pressureHyperinflationRecruitmentComputed tomography

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults admitted to the ICU with severe pneumonia, treated with mechanical ventilation

You may qualify if:

  • 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

You may not qualify if:

  • pneumothorax
  • pneumomediastinum
  • lung CT was obtained with contrast medium to rule out pulmonary embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Milan, Italy

Location

Related Publications (1)

  • 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.

    PMID: 34666011BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

August 8, 2025

Study Start

October 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations