Spontaneous Breathing Trial in ICU
Conditions
Keywords
Ventilator liberation, Spontaneous breathing trial
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.
Interventions
OTHERPressure Support Ventilation (PSV)
Spontaneous breathing trials will be conducted using the mode pressure support ventilation (PSV) with settings of a pressure support of 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O.
OTHERAutomatic tube compensation (ATC)
Spontaneous breathing trials will be conducted using the mode automatic tube compensation (ATC) with settings of 100% tube compensation and a positive end expiratory pressure (PEEP) of 5 cmH2O.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reintubation | Within 48 hours of extubation |
| Death | Within 48 hours of extubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to successful extubation | 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. | The duration (in hours) from the spontaneous breathing trial (SBT) initiation to extubation without reintubation within 48 hours |
| Spontaneous breathing trial (SBT) results | Up to 30 days from study enrollment or until hospital discharge, whichever occurs first. | SBT results (pass or fail) for the first 3 attempts if conducted |
| Reintubation | within 24 hours of extubation | — |
| Use of noninvasive respiratory support | Within 48 hours of extubation | Use of noninvasive ventilation, continuous positive airway pressure (CPAP), and high flow nasal cannula (HFNC) and its duration |
| Total duration of mechanical ventilation | 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. | — |
| Intensive care unit (ICU) length of stay (LOS) | From the date of ICU admission to the date of ICU discharge, assessed up to 30 days. | — |
| Hospital length of stay (LOS) | From the date of hospital admission to the date of hospital discharge, assessed up to 30 days. | — |
| Mortality | At intensive care unit (ICU) discharge | — |
| Clinician adherence to initially assigned spontaneous breathing trial (SBT) mode | Up to 30 days | — |
| Ventilator associated complications | 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. | Including ventilator associated pneumonia, skin pressure ulcers, and barotrauma such as pneumothorax, pneumomediastinum, or subcutaneous emphysema |
Countries
United States
Contacts
CONTACTJie Li, PhD
CONTACTLauren Harnois, MSc
Outcome results
None listed