Safety of Optimal PEEP in NSICU Patients

NCT03862027 | Terminated Results FDA Device

• 1 other identifier: 18-2064
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Failure; Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Cerebral Perfusion Pressure (CPP)

  Immediately before and 5 minutes after ventilator setting change

• Change in Mean Arterial Pressure

  Immediately before and 5 minutes after ventilator setting change

Study Arms (1)

Esophageal Balloon catheter

EXPERIMENTAL

All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed \> 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.

Device: Esophageal Balloon catheter

Interventions

Esophageal Balloon catheter DEVICE

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.

Esophageal Balloon catheter

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Amanda Kovacich, MD
• Organization: University of North Carolina at Chapel Hill

amanda.kovacich@unchealth.unc.edu

919-966-2532

Study Officials

• Shannon Carson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 5, 2019
• Study Start: March 1, 2019
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2019
• Last Updated: April 27, 2021
• Results First Posted: April 1, 2021

Record last verified: 2020-09

Locations

US (1)