NCT03951064

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

Effect of Esophageal Pressure Measurement to Determine Optimal Positive End-expiratory Pressure Compared to Usual Care in Obese Patients Receiving Mechanical Ventilation

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity, Morbid
• Ventilator-Induced Lung Injury
• Respiratory Failure

Interventions

Type	Name	Description
DEVICE	Esophageal balloon	All patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into their nare while upright (head of bed \>30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.
PROCEDURE	Intervention Spontaneous Breathing Trial (SBT) and Extubation	Patients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP.
PROCEDURE	Control Spontaneous Breathing Trial and Extubation	Patients 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.
PROCEDURE	Intervention Weaning after Tracheostomy	Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial only with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway.
PROCEDURE	Control Weaning after Tracheostomy	The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group.

Timeline

• Start date: 2021-03-31
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2019-05-15
• Last updated: 2024-06-05
• Results posted: 2024-06-05

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study