Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon (PROP OPEN)

University of North Carolina (UNC)

Status: Terminated

Conditions: Respiratory Failure; Ventilator-Induced Lung Injury; Obesity, Morbid

Treatments: Procedure: Intervention Weaning after Tracheostomy; Device: Esophageal balloon; Procedure: Control Weaning after Tracheostomy; Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation; Procedure: Control Spontaneous Breathing Trial and Extubation

Study type: Interventional

Funder types: Other

Identifiers

NCT03951064

18-2010

Details and patient eligibility

About

This is a research study to determine if identifying an optimal level of positive end-expiratory pressure (PEEP) targeted specifically to individualized patient characteristics will shorten the time on the ventilator.

Participants will have catheter placed through the nose into the esophagus to measure the pressure inside the chest. This catheter will remain until the patient is freed from the ventilator. Participants will be randomized to usual care or to have the level of PEEP determined by the esophageal balloon pressure readings. The total time spent on the ventilator will be recorded.

Full description

Study Design:

Randomized-controlled clinical trial. Patients will be enrolled within 4 days of mechanical ventilation and randomized 1:1 to titration of PEEP based on esophageal balloon pressures or based on the "High PEEP" ARDSnet PEEP/fraction of inspired oxygen (FiO2) table. All patients will have esophageal balloons placed with baseline measurement of Ptp. Patients randomized to the intervention arm will then undergo titration of PEEP based on Ptp measurements to achieve "Optimal PEEP," defined as end expiratory Ptp of 0 to +2 cm water (H2O).

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index greater than or equal to 40
• Acute respiratory failure requiring mechanical ventilation

Exclusion criteria

• Refusal to give consent by the subject or their legally authorized representative
• Abdominal compartment syndrome
• Chest tube for pneumothorax
• Having been on a ventilator for >4 days
• Suspicion of or known intracranial hypertension
• Anticipated extubation within 24 hours
• Chronic ventilator dependence
• Condition that precludes placement of an esophageal balloon (esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter, severe thrombocytopenia or coagulopathy)
• Incarceration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups

Optimal PEEP

Experimental group

Description:

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).

Treatment:

Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation

Device: Esophageal balloon

Procedure: Intervention Weaning after Tracheostomy

Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP

Active Comparator group

Description:

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.

Treatment:

Procedure: Control Spontaneous Breathing Trial and Extubation

Procedure: Control Weaning after Tracheostomy

Device: Esophageal balloon