Optimal Timing for Spontaneous Breathing Trials
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorRush University Medical Center
About this trial
This study aims to explore how the timing of Spontaneous Breathing Trials (SBTs) affects recovery in adult patients who are on mechanical ventilation in the ICU. SBTs are tests used to determine if a patient is ready to breathe on their own without the help of a ventilator. The study will compare two different timing strategies for these trials: one group of patients will have the test early in the morning, while the other group will have it later in the morning. By observing the outcomes, such as how long patients need to stay on the ventilator, the study hopes to find the best time to perform these trials to help patients recover more quickly and safely.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 21 years or older.
Patients who have been on mechanical ventilation for more than 48 hours.
Patients who have completed at least one SBT.
Disqualifiers
Patients intubated at other hospitals.
Patients intubated for surgical or interventional procedures.
Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO).
Patients with a tracheostomy.
Trial design
Design model
Parallel
Treatments tested in this trial
Later Morning Timing of Spontaneous Breathing Trials
Other interventionLater Morning Group: Patients in this group will have their SBTs scheduled between 8:00 AM and 9:00 AM, closer to the time of day shift rounds.
Treatment groups
348 Participants
are divided into 2 treatment groupsGroup A: Early morning timing of spontaneous breathing trialNo intervention 0 interventions
Group B: Later morning timing of spontaneous breathing trialExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
mechanical ventilation duration
The primary outcome of this study is the duration of mechanical ventilation, which refers to the total number of days a patient remains on a mechanical ventilator in the ICU. This measure begins from the moment a patient is initially placed on the ventilator and continues until the patient is successfully extubated (the breathing tube is removed) and can breathe independently without the need for ventilatory support.
Time frame
From enrollment to the end of study at 28 daysSecondary outcomes
1
Duration Between SBT Success and Extubation
This outcome measures the time interval (in hours) between when a patient successfully passes a Spontaneous Breathing Trial (SBT) and when they are extubated. A successful SBT indicates that the patient is likely ready to breathe independently without mechanical support.
Time frame
From enrollment to the end of study at 28 days2
ICU and Hospital Mortality
This outcome records the percentage of patients who die while in the ICU or during their overall hospital stay.
Time frame
From enrollment to the end of study at 28 days3
ICU and Hospital Lengths of Stay
This outcome measures the total number of days a patient remains in the ICU and the hospital from admission to discharge.
Time frame
From enrollment to the end of study at 28 days4
Reintubation Rates
This outcome measures the percentage of patients who require reintubation within 48 hours of being extubated.
Time frame
From enrollment to the end of study at 28 daysSponsors and contacts
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Source ClinicalTrials.gov