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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
6
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.
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.
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.
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.
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.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Number of Ventilator-Free Days (VFD) by Day 28
The number of days a patient is alive and free from the ventilator up to day 28.
Time frame: 28 days
Number of Participants Reintubated
Intubated within 72 hours of extubation
Time frame: 72 hours after extubation
ICU Length of Stay
Number of days spent in the ICU
Time frame: maximum duration of ICU stay, up to 46 days
Hospital Length of Stay
Number of days spent in the Hospital
Time frame: maximum duration of hospital stay, up to 83 days
Number of Patients Receiving a Tracheostomy
Whether the patient required a tracheostomy to be liberated from the ventilator
Time frame: during mechanical ventilation, up to 28 days
Number of Patients Extubated Early
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.
Time frame: 28 days
Highest Richmond Agitation and Sedation Scale
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.
Time frame: during mechanical ventilation, up to 28 days
Lowest Richmond Agitation and Sedation Scale
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.
Time frame: during mechanical ventilation, up to 28 days
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