NCT05209477

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 13, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 13, 2022

Last Update Submit

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

OTHER

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

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

Lung ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università degli Studi di Perugia

Perugia, Umbria, Italy, 06156, Italy

Location

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

Locations