Clinical trial NCT07005505: Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Adults
Official title: Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Critically Ill Adults: A Cluster-Randomized, Cluster-Crossover Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spontaneous Breathing Trial in ICU
Keywords: Ventilator liberation
Spontaneous breathing trial
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: During the first month of the study, each intensive care unit (ICU) will be randomly assigned to one mode of spontaneous breathing trial (SBT). Each month thereafter, each ICU will independently alternate between the two modes. Patients will be analyzed based on the group to which they were assigned at enrollment (intention-to-treat), even if they remain in the study ICU during a transition from one month to the next or transfer to another ICU assigned to the opposite SBT mode ("crossover"). The last three days of each month will serve as an analytic washout period, during which the study ICU will continue using the assigned ventilator mode, but new patients will not be included in the primary analysis. This three-day washout period is intended to minimize the number of patients experiencing a "crossover" between assigned modes within the 72-hour timeframe used to assess feasibility outcomes and adherence.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reintubation
timeFrame: Within 48 hours of extubation
measure: Death
timeFrame: Within 48 hours of extubation
Secondary outcomes:
measure: Time to successful extubation
timeFrame: From the start of the first spontaneous breathing trial (SBT) to the first successful extubation (without reintubation within 48 hours) or death from any cause, whichever occurred first, assessed up to 30 days.
measure: Spontaneous breathing trial (SBT) results
timeFrame: Up to 30 days from study enrollment or until hospital discharge, whichever occurs first.
measure: Reintubation
timeFrame: within 24 hours of extubation
measure: Reintubation
timeFrame: Within 72 hours of extubation
measure: Reintubation
timeFrame: Within 7 days of extubation
measure: Use of noninvasive respiratory support
timeFrame: Within 48 hours of extubation
measure: Total duration of mechanical ventilation
timeFrame: From the date of intubation to the date of extubation without reintubation within 28 hours or date of death from any cause, whichever occurs first, assessed up to 30 days.
measure: Intensive care unit (ICU) length of stay (LOS)
timeFrame: From the date of ICU admission to the date of ICU discharge, assessed up to 30 days.
measure: Hospital length of stay (LOS)
timeFrame: From the date of hospital admission to the date of hospital discharge, assessed up to 30 days.
measure: Mortality
timeFrame: At intensive care unit (ICU) discharge
measure: Mortality
timeFrame: Up to 30 days
measure: Clinician adherence to initially assigned spontaneous breathing trial (SBT) mode
timeFrame: Up to 30 days
measure: Ventilator associated complications
timeFrame: From the date of intubation to the date of extubation without reintubation in 48 hours or death from any cause, whichever occurs first, assessed up to 30 days.
Other outcomes:
Locations:
Study officials:
References:
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