Effect of Positive End Expiratory Pressure on Diaphragmatic Fraction Assessed Through Ultrasound in Intubated Patient Undergoing Assisted Ventilation
1 other identifier
observational
30
1 country
1
Brief Summary
The investigators aim to assess the effects of positive end-expiratory pressure (PEEP) on diaphragmatic activity evaluated through ultrasound in patients admitted to intensive care unit (ICU) for acute respiratory failure (ARF) assisted via invasive mechanical ventilation in assisted mode.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2022
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
October 23, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedMarch 14, 2022
February 1, 2022
3 months
October 23, 2021
February 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Diaphragmatic thickening fraction
The fraction of diaphragmatic thickness variations expressed in percentage during a stepwise decrease in positive end-expiratory pressure (PEEP)
20 minutes
Secondary Outcomes (7)
Lung aeration
20 minutes
Peripheral oxygen saturation
20 minutes
Electrical activity of the diaphragm (optional)
20 minutes
Inspired oxygen fraction
20 minutes
Expiratory Tidal volume
20 minutes
- +2 more secondary outcomes
Interventions
patients will be invasively ventilated in assisted mode. In all enrolled patients ventilated in assisted mode. Diaphragmatic activity will be evaluated through ultrasound (primary end point) and electrical activity of the diaphragm (optional) at stepwise decreasing of PEEP level. Also, the activity of remaining respiratory muscles will be assessed through sonography at the same levels of PEEP (secondary end point).
Eligibility Criteria
All adult patient admitted in intensive care unit for hypoxemic acute respiratory failure, undergoing invasive mechanical ventilation for more than 48 hours and, after this time, ventilated in Assisted Ventilation, i.e., pressure support ventilation (PSV)
You may qualify if:
- age \> 18 years
- invasive mechanical ventilation \> 48 hours
You may not qualify if:
- pregnancy
- neuromuscular disease
- wounds or incision at the probe placement site.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Università degli Studi di Perugia
Perugia, Umbria, Italy, 06156, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Prophessor
Study Record Dates
First Submitted
October 23, 2021
First Posted
November 18, 2021
Study Start
March 1, 2022
Primary Completion
May 31, 2022
Study Completion
August 31, 2022
Last Updated
March 14, 2022
Record last verified: 2022-02