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

Withdrawn

• Conditions: Acute Respiratory Failure; Acute Respiratory Distress Syndrome

• Registration Number: NCT05958862
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-20
• Study First Posted: 2023-07-25
• Study Start: 2024-07-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stability of change in Driving Pressure after PEEP manipulation	10 minutes total	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.