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NCT Number: NCT05209477

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

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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Key information

Conditions

Acute Respiratory Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università degli Studi di Perugia

Perugia, Umbria, Italy, 06156, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients intubated for COVID-19 hARF -

Exclusion criteria

Any contraindication to recruitment and lung ultrasound, pregnancy

-

Treatment and study plan

lung ultrasound assessment

Other

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:

  • baseline, in supine position under protective ventilation
  • after two minute of recruitment maneuver in pressure controlled ventilation
  • at 1 hour following prone positioning application

Primary outcomes

  1. lung ultrasound score

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

    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

  2. lung ultrasound score recruitment

    Time frame: 2 minutes

    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

  3. lung ultrasound score prone positioning

    Time frame: 1 hour

    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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Perugia

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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