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
1 other identifier
interventional
25
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 13, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedJanuary 31, 2024
January 1, 2024
6 months
January 13, 2022
January 29, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
Lung ultrasound
OTHERn 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
Interventions
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
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Università degli Studi di Perugia
Perugia, Umbria, Italy, 06156, Italy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Gianmaria Cammarota md, phd
Study Record Dates
First Submitted
January 13, 2022
First Posted
January 26, 2022
Study Start
December 1, 2021
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
January 31, 2024
Record last verified: 2024-01