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

NCT05958862 | Withdrawn DMC

• 1 other identifier: IRB-300010038
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Respiratory Failure; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ryan L Goetz, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary and Critical Care Medicine Fellow

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 25, 2023
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share