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

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Failure
• Intervention / Treatment: Other: lung ultrasound assessment

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Umbria, Italy
    • Perugia, Umbria, Italy, Italy, 06156
      • Università degli Studi di Perugia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Patients intubated for COVID-19 hARF -

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera di Perugia

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome
• Other Study ID Numbers: 12/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No