Safety of Optimal PEEP in NSICU Patients

Respiratory Failure Clinical Trial

Official title:

Evaluating Safety of Transpulmonary Pressure Guided PEEP Management in Neurocritical Care Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03862027
• Other study ID #: 18-2064
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 4, 2019

Study information

• Verified date: September 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Purpose: To establish safety of titrating PEEP based on transpulmonary pressure as measured by an esophageal balloon in mechanically ventilated neurosurgical patients.

Participants: Adult patients admitted to the Neuro ICU at UNC Hospital and requiring mechanical ventilation who have an intracranial pressure monitoring device in place.

Procedures (methods): All enrolled patients will have esophageal balloons placed with measurement of transpulmonary pressures. All patients will have baseline measurements recorded of intracranial pressure, cerebral perfusion pressure, and cerebral autoregulation. PEEP will then be titrated based on transpulmonary pressure measurements with recording of physiological measurements over the next hour. At the conclusion of the hour, all patients will be returned to their prior ventilator settings.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 4, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Pneumothorax or pneumomediastinum

2. Life expectancy < 24 hours or expected to require mechanical ventilation for < 24 hours

3. 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).

4. Pre-enrollment ICP > 20 mm Hg

5. Pre-enrollment CPP < 60 mm Hg

6. Planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods

7. Incarceration

8. Variation in ICP of > 2 cm H2O in the hour prior to intervention.

Related Conditions & MeSH terms

• Intracranial Hypertension
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Esophageal Balloon catheter
Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP"). Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ICP Value	The Intracranial pressure (ICP) value after intervention will be considered equivalent to the ICP before intervention if the 95% upper bound of the change is lower than the non-inferiority margin of 4 mm Hg.	Within 5 minutes of catheter placement
Secondary	Change in Cerebral Perfusion Pressure (CPP)	Cerebral perfusion pressure is equal to the mean arterial pressure (MAP) minus the intracranial pressure (ICP). The initial CPP is calculated by measuring CPP immediately before changing ventilator settings. The post-intervention CPP is measured 5 minutes after ventilator setting change is made. The difference between the initial CPP and the post-intervention CPP reflects the change in CPP.	Immediately before and 5 minutes after ventilator setting change
Secondary	Change in Mean Arterial Pressure	Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.	Immediately before and 5 minutes after ventilator setting change