Back to resultsEffects 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
Primary Purpose
Acute Respiratory Failure
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
lung ultrasound assessment
Sponsored by
About this trial
This is an interventional other trial for Acute Respiratory Failure
Eligibility Criteria
Inclusion Criteria: Patients intubated for COVID-19 hARF -
Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy
-
Sites / Locations
- Università degli Studi di PerugiaRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Lung ultrasound
Arm Description
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
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05209477
First Posted
January 13, 2022
Last Updated
January 26, 2022
Sponsor
Azienda Ospedaliera di Perugia
1. Study Identification
Unique Protocol Identification Number
NCT05209477
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera di Perugia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lung ultrasound
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
lung ultrasound assessment
Intervention Description
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
Primary Outcome Measure Information:
Title
lung ultrasound score
Description
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
Time Frame
after 20 minutes following study entry, in volume controll ventilation and supine position
Title
lung ultrasound score recruitment
Description
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
Time Frame
2 minutes
Title
lung ultrasound score prone positioning
Description
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
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients intubated for COVID-19 hARF -
Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gianmaria Cammarota, Md, Phd
Phone
+39075 5783594
Email
gianmaria.cammarota@unipg.it
Facility Information:
Facility Name
Università degli Studi di Perugia
City
Perugia
State/Province
Umbria, Italy
ZIP/Postal Code
06156
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianmaria Cammarota
Phone
039755783594
Email
gianmaria.cammarota@unipg.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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
We'll reach out to this number within 24 hrs