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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05209477
Other study ID # 12/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date May 31, 2022

Study information

Verified date January 2024
Source Azienda Ospedaliera di Perugia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients intubated for COVID-19 hARF - Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy -

Study Design


Intervention

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

Locations

Country Name City State
Italy Università degli Studi di Perugia Perugia Umbria, Italy

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera di Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 after 20 minutes following study entry, in volume controll ventilation and supine position
Primary 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 2 minutes
Primary 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 1 hour
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