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

ConditionSpontaneous Breathing Trial in ICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Clinical decision made not to proceed with extubation regardless of spontaneous breathing trial (SBT) results

Do not intubate (DNI) order

Presence of tracheostomy

Pregnancy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Pressure Support Ventilation (PSV)

    Other intervention

    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.

  • Automatic tube compensation (ATC)

    Other intervention

    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.

Treatment groups

880 Participants
are divided into 4 treatment groups
Group A: Adult Intensive Care Unit (AICU)Experimental treatment 2 interventions
Group B: Medical Intensive Care Unit (MICU)Experimental treatment 2 interventions
Group C: Cardiosciences Intensive Care Unit (CSICU)Experimental treatment 2 interventions
Group D: Neuroscience Intensive Care Unit (NSICU)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Reintubation

Time frame
Within 48 hours of extubation
2

Death

Time frame
Within 48 hours of extubation

Secondary outcomes

1

Time to successful extubation

The duration (in hours) from the spontaneous breathing trial (SBT) initiation to extubation without reintubation within 48 hours

Time frame
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.
2

Spontaneous breathing trial (SBT) results

SBT results (pass or fail) for the first 3 attempts if conducted

Time frame
Up to 30 days from study enrollment or until hospital discharge, whichever occurs first.
3

Reintubation

Time frame
within 24 hours of extubation
4

Reintubation

Time frame
Within 72 hours of extubation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rush University Medical Center

Lead sponsor

Source ClinicalTrials.gov
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