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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure

• Study Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult medical intensive care patients undergoing invasive mechanical ventilation who meet above inclusion/exclusion criteria

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Ryan L Goetz, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury
• Other Study ID Numbers: IRB-300010038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual patient level data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No