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CompletedNCT05209477Updated Jan 31, 2024

Effects of Body Position and Recruiting Maneuver on Lung Aeration Assessed Through Ultrasound in Patients Intubated for Acute Respiratory Failure Related to Novel Coronavirus 19 Disease

An interventional study of lung ultrasound assessment in Acute Respiratory Failure, sponsored by Azienda Ospedaliera di Perugia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Azienda Ospedaliera di Perugia · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation

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Conditions studied

03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 25 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Azienda Ospedaliera di Perugia is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Patients intubated for COVID-19 hARF -

Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy

-

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Other
    Lung ultrasound

    n patients undergoing invasive mechanical ventilation with an arterial oxygen tension on inspired oxygen fraction ratio \< 200 mmHg requiring recruitment maneuver and prone positioning as a rescue therapy, lung aeration will be evaluated at: baseline, in supine position under protective ventilation after two minute of recruitment maneuver in pressure controlled ventilation at 1 hour following prone positioning application

    Other: lung ultrasound assessment

Interventions

  • Otherlung ultrasound assessment

    In patients undergoing invasive mechanical ventilation with an arterial oxygen tension on inspired oxygen fraction ratio \< 200 mmHg requiring recruitment maneuver and prone positioning as a rescue therapy, lung aeration will be evaluated at: 1. baseline, in supine position under protective ventilation 2. after two minute of recruitment maneuver in pressure controlled ventilation 3. at 1 hour following prone positioning application

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What researchers measure

Primary outcomes

  1. lung ultrasound score

    lung aeration evaluated through ultrasound during protective invasive mechanical in supine position. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration

    Time frame: after 20 minutes following study entry, in volume controll ventilation and supine position

  2. lung ultrasound score recruitment

    lung aeration evaluated through ultrasound during protective invasive mechanical ventilation in supine position after two minutes of recruiting maneuver in pressure controlled ventilation. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration

    Time frame: 2 minutes

  3. lung ultrasound score prone positioning

    lung aeration evaluated through ultrasound during protective invasive mechanical ventilation after 1 h from prone position application. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration

    Time frame: 1 hour

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Study locations

1 site
  • Università degli Studi di Perugia
    Perugia, Umbria, Italy 06156, Italy
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05209477
Lead sponsor
Azienda Ospedaliera di Perugia
Responsible party
Prof Gianmaria Cammarota (Prof Gianmaria Cammarota md, phd, Azienda Ospedaliera di Perugia) — Principal investigator
First posted
Jan 26, 2022
Start date
Dec 1, 2021
Primary completion
May 31, 2022
Completion
May 31, 2022
Last update
Jan 31, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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