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

Acute Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209477
• Other study ID #: 12/21
• Status: Completed
• Phase: N/A
• 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
• 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 -

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Insufficiency

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