Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon

Not Applicable

Terminated

• Conditions: Obesity, Morbid; Ventilator-Induced Lung Injury; Respiratory Failure
• Interventions: Device: Esophageal balloon; Procedure: Intervention Spontaneous Breathing Trial (SBT) and Extubation; Procedure: Control Spontaneous Breathing Trial and Extubation; Procedure: Control Weaning after Tracheostomy; Procedure: Intervention Weaning after Tracheostomy

• Registration Number: NCT03951064
• Lead Sponsor: University of North Carolina, Chapel Hill

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 Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2021-03-31
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Status Verified: 2024-03
• Results First Submitted: 2024-03-19
• Results First Submitted QC: 2024-06-04
• Last Update Submitted: 2024-06-04
• Results First Posted: 2024-06-05
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimal PEEP	Esophageal balloon	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).
Optimal PEEP	Intervention Spontaneous Breathing Trial (SBT) and Extubation	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).
Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP	Esophageal balloon	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.
Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP	Control Weaning after Tracheostomy	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.
Optimal PEEP	Intervention Weaning after Tracheostomy	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).
Acute Hypoxic Respiratory Distress Syndrome Network (ARDSNet) High PEEP	Control Spontaneous Breathing Trial and Extubation	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.

Primary Outcome Measures

Name	Time	Method
Number of Ventilator-Free Days (VFD) by Day 28	28 days	The number of days a patient is alive and free from the ventilator up to day 28.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Receiving a Tracheostomy	during mechanical ventilation, up to 28 days	Whether the patient required a tracheostomy to be liberated from the ventilator
ICU Length of Stay	maximum duration of ICU stay, up to 46 days	Number of days spent in the ICU
Number of Participants Reintubated	72 hours after extubation	Intubated within 72 hours of extubation
Lowest Richmond Agitation and Sedation Scale	during mechanical ventilation, up to 28 days	Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the lowest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome.
Hospital Length of Stay	maximum duration of hospital stay, up to 83 days	Number of days spent in the Hospital
Number of Patients Extubated Early	28 days	Extubation prior to meeting established criteria (Control group only). Participants in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.
Highest Richmond Agitation and Sedation Scale	during mechanical ventilation, up to 28 days	Measures the mental and physical state of a sedated patient. Range from -5 to +4. A score of 0 indicates a calm arousable patient and is the ideal score. A score of +4 indicates a very combative participant and a score of -5 indicates an unarousable participant. This outcome captures the highest score measured throughout mechanical ventilation with scores on the extreme ends of the range reflecting a worse outcome.

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States