Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Adults

Rush

Status: Enrolling

Conditions: Spontaneous Breathing Trial in ICU

Treatments: Other: Automatic tube compensation (ATC); Other: Pressure Support Ventilation (PSV)

Study type: Interventional

Funder types: Other

Identifiers

NCT07005505

25031208

Details and patient eligibility

About

For patients requiring mechanical ventilation, spontaneous breathing trials (SBTs) are conducted to determine if it is safe to remove the breathing tube. There are multiple methods for conducting SBTs. The purpose of this study is to compare the effects of 2 methods, pressure support ventilation (PSV) versus automatic tube compensation (ATC), on successful extubation for critically ill adult patients who received mechanical ventilation for over 24 hours.

Full description

The delivery of pressure support through the ventilator can be fixed using the pressure support ventilation (PSV) mode or variable using the automatic tube compensation (ATC) mode. Similar to PSV, ATC provides pressure support but dynamically adjusts it to compensate the resistive work of breathing and the mechanical load on respiratory muscles imposed by an artificial airway, such as an endotracheal or tracheostomy tube. Although both ATC and PSV are licensed and used in clinical practice, the optimal method to deliver pressure support during a spontaneous breathing trial (SBT) remains unknown. At Rush University Medical Center, ATC has been used for SBTs for over a decade. However, given the growing popularity of PSV, the SBT protocol was updated and now approves the use of PSV and ATC as standard care for SBT without making a recommendation for a preferred mode. The choice between PSV and ATC during SBT is left to the discretion of the clinician, reflecting the ongoing equipoise in the conduct of the SBT. As patients will be exposed to the potential benefits and risks of PSV or ATC under this change in clinical practice, the investigators are conducting a cluster-randomized cluster-crossover trial to compare the mode's effect on successful extubation.

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted to intensive care unit (ICU)
• Age 18 years or older
• Requiring invasive mechanical ventilation for at least 24 hours
• Pass spontaneous breathing trial screen criteria

Exclusion criteria

• Clinical decision made not to proceed with extubation regardless of spontaneous breathing trial (SBT) results
• Do not intubate (DNI) order
• Presence of tracheostomy
• Pregnancy
• Known prisoner
• Immediate need for extubation, self-extubation, or unplanned extubation that precludes safe performance of study procedures
• Enrolled in another clinical trial that impacts ventilator weaning or liberation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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880 participants in 4 patient groups

Adult Intensive Care Unit (AICU)

Experimental group

Treatment:

Other: Pressure Support Ventilation (PSV)

Other: Automatic tube compensation (ATC)

Medical Intensive Care Unit (MICU)

Experimental group

Treatment:

Other: Pressure Support Ventilation (PSV)

Other: Automatic tube compensation (ATC)

Cardiosciences Intensive Care Unit (CSICU)

Experimental group

Treatment:

Other: Pressure Support Ventilation (PSV)

Other: Automatic tube compensation (ATC)

Neuroscience Intensive Care Unit (NSICU)

Experimental group

Treatment:

Other: Pressure Support Ventilation (PSV)

Other: Automatic tube compensation (ATC)