Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" Trial
Conditions: Acute Respiratory Failure, Acute Respiratory Distress Syndrome
Sponsor: University of Alabama at Birmingham

 
 
Stability of Driving Pressure Changes During "Best Positive End Expiratory Pressure (PEEP)" 
Trial 
 
 
NCT number: applied for  
 
Document date: 6/27/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Trial Protocol: 
 
During study periods, a pulmonary/critical care medicine fellow physician (fellow) will screen 
patients following intubations in Medical Intensive Care Unit (MICU) and Medical Critical Care 
Unit (MCCU). Following the intubation and initial stabilization (within 30 minutes of intubation), 
the fellow will increase PEEP by 3 followed by serial measurements of plateau pressure at 3 
breaths, 30 seconds, 1 minute, 5 minutes, and 10 minutes. At the end of 10 minutes, PEEP will 
again be increased by 3, with repeat measurements of plateau pressure at 3 breaths, 30 
seconds, 1 minute, 5 minutes, and 10 minutes. The PEEP would returned to the original value 
and the results will then be communicated to the treating ICU team. 
Given that the post-intubation period is a critical time point in patient's ICU stays and risk of 
decompensation regardless of the performance of an "optimal PEEP trial". Fellow will remain at 
bedside throughout the trial and is to increase FiO2 if patient oxygen saturation drops below 
90%. If the patient develops hemodynamic or other instability, as determined by the fellow, the 
trial will be ended and the fellow will proceed with standard interventions to stabilize the 
patient. The results at time of instability will be recorded in addition to a qualitative 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). 
 
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 
 
 
Statistical plan:  
We based our power calculations around a small pilot study (Sahetya et al). They demonstrated 
a mean driving pressure at 15 minutes of 13.89 with standard deviation is 2.63 (based on 
personal communication with first author). Based on an effect size of 80% and alpha of 0.05, we 

will use a sample size of 50 to obtain adequate statistical power to exclude a clinically 
significant difference of 1 mmHg. Citation: PEEP Titration to Minimize Driving Pressure in 
Subjects With ARDS: A Prospective Physiological Study. Sarina K Sahetya, David N Hager, R Scott 
Stephens, Dale M Needham, Roy G Brower. Respiratory Care May 2020, 65 (5) 583-589; DOI: 
10.4187/respcare.07102