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NCT05958862 Clinical Trial

Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05958862
Other study ID # IRB-300010038
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2025

Study information
Verified date January 2024
Source University of Alabama at Birmingham
Contact Ryan L Goetz, MD
Phone 205-996-5864
Email rgoetz@uabmc.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The goal of this study is to better understand in changes in lung compliance as indicated by driving pressure (a non-invasive marker) following changes in positive end expiratory pressure (PEEP; a standard of care ventilator parameter). The main question it aims to answer is: The time to stability of driving pressure after a change in PEEP is made Type of study: observational study participant population/health conditions Participants will undergo a "best PEEP trial" which is a standard intensive care intervention for patients undergoing invasive mechanical ventilation. This involves changing the patient's PEEP and looking for response in driving pressure. This will be done in a more protocolized format and data will be collected.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 30, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Adult patients >18 years of age - Undergoing intubation and mechanical ventilation in Medical Intensive Care Unit (MICU) or Medical Critical Care Unit (MCCU) at the University of Alabama Birmingham. Exclusion Criteria: - Prisoner - Pregnant - Age <18 years of age - Intensive Care Unit (ICU) team declines participation - Unstable oxygenation (requiring 100% FiO2 to maintain saturations greater than 90% oxygen saturation following initial PEEP titration by primary team) - Hemodynamic instability: vasopressor requirement of >0.3 mcg/kg/min of norepinephrine or equivalent - Pneumomediastinum - Pneumothorax without chest tube - Previous enrolled in trial - Need for immediate travel out of ICU following intubation for procedures, tests

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome
Type Measure Description Time frame Safety issue
Primary Stability of change in Driving Pressure after PEEP manipulation Our study attempts to find the time point when driving pressure reaches stability. The primary outcome will be the first time point (3 breaths, 30 seconds, 1 minute, 3 minutes, 5 minutes, 10 minutes) where driving pressure is not statistically different from the baseline measurement. 10 minutes total
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