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Tailored PEEP with Esophageal Balloon for Ventilated Obese Patients (PROP OPEN Trial)

N/A

Waitlist Available

Led By Thomas Bice, MD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute respiratory failure requiring mechanical ventilation

Be older than 18 years old

Must not have

Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)

Suspicion of or known intracranial hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up maximum duration of hospital stay, up to 83 days

Awards & highlights

No Placebo-Only Group

Summary

This trialwill test if a tailored approach to PEEP can help patients get off ventilators faster.

Who is the study for?

This trial is for obese patients with a body mass index (BMI) of 40 or higher who are experiencing acute respiratory failure and require mechanical ventilation. It's not suitable for those dependent on ventilators long-term, unable to consent, with specific abdominal or chest conditions, expected to be extubated within a day, at risk of high brain pressure, or with issues that prevent esophageal balloon placement.

What is being tested?

The study aims to see if using an esophageal balloon to measure chest pressure can help find the best level of PEEP (positive end-expiratory pressure) for each patient and reduce time spent on a ventilator. Participants will either receive usual care or have their PEEP adjusted based on readings from the esophageal balloon.

What are the potential side effects?

Potential side effects may include discomfort from the catheter placed through the nose into the esophagus and risks associated with incorrect PEEP levels such as lung injury or breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on a breathing machine due to severe breathing problems.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have an esophageal balloon due to certain health issues.

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I might have or am known to have high pressure in my brain.

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I have a chest tube for a collapsed lung.

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I have been diagnosed with abdominal compartment syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ maximum duration of hospital stay, up to 83 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~maximum duration of hospital stay, up to 83 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and maximum duration of hospital stay, up to 83 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Ventilator-Free Days (VFD) by Day 28

Secondary study objectives

Highest Richmond Agitation and Sedation Scale

Hospital Length of Stay

ICU Length of Stay

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Optimal PEEPExperimental Treatment3 Interventions

The waveforms of airway pressure (Paw), esophageal pressure (Pes), and transpulmonary pressure (Ptp) will be visualized on the ventilator. Ptp is obtained from Paw - Pes. PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP). Measurements will be obtained daily and adjustments to PEEP will occur daily. PEEP will be reduced below Optimal PEEP in the setting of hemodynamic compromise (requiring increasing vasoactive medications for blood pressure support).

Group II: Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEPActive Control3 Interventions

PEEP in the control group will be determined by High PEEP ARDSnet PEEP/FiO2 table. Titration of PEEP will occur when clinically indicated by partial pressure of oxygen (PaO2) or oxygen saturation (SpO2), and FiO2. The investigators chose the High PEEP table based on the clinical suspicion that obese patients may require higher PEEP levels on average than non-obese patients to balance the additional pressure of their chest wall. In addition, EPVent2, a study of esophageal balloon PEEP titration in patients with ARDS utilized the High PEEP table. Patients with moderate and severe ARDS benefit from higher levels of PEEP.

0 / 5Eligibility criteria met