Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Number of Ventilator-Free Days (VFD) by Day 28
Study Overview
Brief Summary
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.
Detailed 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the obvious treatment differences between the two groups, blinding of treatment group will be impossible. However, the investigators will have one outcome assessor who will have access only to the data necessary to determine the primary outcome (Ventilator-Free Days at 28-days), and this assessor will be blinded to treatment group using built-in REDCap tools.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Optimal PEEP
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).
Intervention: Esophageal balloon (Device)
Optimal PEEP
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).
Intervention: Intervention Spontaneous Breathing Trial (SBT) and Extubation (Procedure)
Optimal PEEP
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).
Intervention: Intervention Weaning after Tracheostomy (Procedure)
Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP
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.
Intervention: Esophageal balloon (Device)
Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP
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.
Intervention: Control Spontaneous Breathing Trial and Extubation (Procedure)
Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP
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.
Intervention: Control Weaning after Tracheostomy (Procedure)
Outcomes
Primary Outcomes
Number of Ventilator-Free Days (VFD) by Day 28
Time Frame: 28 days
The number of days a patient is alive and free from the ventilator up to day 28.
Secondary Outcomes
- ICU Length of Stay(maximum duration of ICU stay, up to 46 days)
- Number of Patients Receiving a Tracheostomy(during mechanical ventilation, up to 28 days)
- Number of Participants Reintubated(72 hours after extubation)
- Lowest Richmond Agitation and Sedation Scale(during mechanical ventilation, up to 28 days)
- Hospital Length of Stay(maximum duration of hospital stay, up to 83 days)
- Number of Patients Extubated Early(28 days)
- Highest Richmond Agitation and Sedation Scale(during mechanical ventilation, up to 28 days)