Clinical trial NCT03951064: Providing Optimal PEEP During Mechanical Ventilation for Obese Patients Using Esophageal Balloon
Official title: Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Morbid
Ventilator-Induced Lung Injury
Respiratory Failure
Keywords: Transpulmonary pressure
Esophageal balloon
Esophageal pressure monitoring
Mechanical ventilation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: East Carolina University
First posted: 2019-05-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Ventilator-Free Days (VFD) by Day 28
timeFrame: 28 days
Secondary outcomes:
measure: Number of Participants Reintubated
timeFrame: 72 hours after extubation
measure: ICU Length of Stay
timeFrame: maximum duration of ICU stay, up to 46 days
measure: Hospital Length of Stay
timeFrame: maximum duration of hospital stay, up to 83 days
measure: Number of Patients Receiving a Tracheostomy
timeFrame: during mechanical ventilation, up to 28 days
measure: Number of Patients Extubated Early
timeFrame: 28 days
measure: Highest Richmond Agitation and Sedation Scale
timeFrame: during mechanical ventilation, up to 28 days
measure: Lowest Richmond Agitation and Sedation Scale
timeFrame: during mechanical ventilation, up to 28 days
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Shannon Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Obi ON, Mazer M, Bangley C, Kassabo Z, Saadah K, Trainor W, Stephens K, Rice PL, Shaw R. Obesity and Weaning from Mechanical Ventilation-An Exploratory Study. Clin Med Insights Circ Respir Pulm Med. 2018 Sep 18;12:1179548418801004. doi: 10.1177/1179548418801004. eCollection 2018.
citation: Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.