Safety of Optimal PEEP in NSICU Patients

Stopped early · Not applicable

Conditions studied: Respiratory Failure, Intracranial Hypertension

In brief

The investigators aim to demonstrate that use of transpulmonary pressure to guide PEEP management is safe in patients with possible elevations of intracranial pressure.

Key facts

Study ID

NCT03862027

Run by

University of North Carolina, Chapel Hill

People needed

1

Starts

2019-03-01

Expected to finish

2019-03-04

Last updated by the study team

2021-04-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (age >/= 18) admitted to the Neuro ICU of UNC Hospital requiring mechanical ventilation and with ICP monitoring in place.

You may not qualify if…

• Pneumothorax or pneumomediastinum
• Life expectancy < 24 hours or expected to require mechanical ventilation for < 24 hours
• Condition that precludes placement of an esophageal balloon [esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter (esophageal ulcerations, tumors, diverticulitis, bleeding varices or in patients with sinusitis, epistaxis or recent nasopharyngeal surgery), severe thrombocytopenia (platelet count < 30) or coagulopathy (INR > 3 or on oral anticoagulants).
• Pre-enrollment ICP > 20 mm Hg
• Pre-enrollment CPP < 60 mm Hg
• Planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods
• Incarceration
• Variation in ICP of > 2 cm H2O in the hour prior to intervention.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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