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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05958862

Enrollment

Registered

2023-07-25

Start date

2024-07-01

Completion date

2025-06-30

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Acute Respiratory Failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results