Timing of Breathing Tests for Patients on Ventilators

Overseen By JIE LI, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Intubated elsewhere, VV-ECMO, tracheostomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days

348 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the timing of breathing tests for ICU patients on ventilators, comparing early morning and later morning (Later Morning Timing of Spontaneous Breathing Trials) to determine which timing aids faster recovery and earlier ventilator removal. Patients who have been on a ventilator for over two days and have attempted independent breathing once may qualify. As an unphased trial, it provides patients the chance to contribute to significant research that could enhance ICU care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the timing of Spontaneous Breathing Trials is safe for patients on ventilators?

Research shows that spontaneous breathing trials (SBTs) are a safe and important method to help patients come off ventilators. Previous studies demonstrated that using an SBT protocol allowed patients to be removed from the ventilator sooner, which is crucial because prolonged ventilation can lead to complications.

One study found that performing SBTs once a day enabled patients to leave the ventilator earlier compared to other methods. This suggests that the timing and consistency of these tests significantly impact recovery.

Regarding safety, these studies did not identify major concerns about the risk of SBTs, which are generally well-tolerated by patients. The focus remains on determining the optimal time of day to conduct these trials to enhance patient recovery. The trial under consideration is exploring whether conducting the test later in the morning might offer more benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether the timing of spontaneous breathing trials (SBTs) for patients on ventilators can make a difference in outcomes. Traditionally, these tests are done early in the morning, between 4:00 AM and 5:00 AM. This study is testing if scheduling SBTs later, between 8:00 AM and 9:00 AM, closer to when the day shift starts, might improve patient readiness or recovery. By potentially aligning the test with the natural body rhythms or the presence of more staff, researchers hope to optimize the process, making it more efficient and possibly more effective.

What evidence suggests that the timing of Spontaneous Breathing Trials is effective for patients on ventilators?

This trial will compare the timing of spontaneous breathing trials (SBTs) for patients on ventilators. Research has shown that altering the timing of SBTs can help patients come off ventilators faster. SBTs assess whether a patient can breathe independently with minimal ventilator support. Studies have found that conducting these tests daily can increase the chances of successfully removing patients from ventilators. By comparing different times for these tests, such as early morning versus later morning, the trial aims to identify the optimal timing. This can lead to quicker patient recovery and more days without needing a ventilator. ^{1 6 7 8 9}

Who Is on the Research Team?

JIE LI, PhD

Principal Investigator

Rush University

Are You a Good Fit for This Trial?

This trial is for adult ICU patients who are currently on mechanical ventilation. It's designed to see if the timing of a breathing test, which checks if they can breathe without help, affects their recovery.

Inclusion Criteria

I am 21 years old or older.

I have been on a breathing machine for more than 2 days.

I have completed at least one session of brief therapy.

Exclusion Criteria

Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO)

I was intubated for a surgery or procedure.

I have a tracheostomy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo Spontaneous Breathing Trials (SBTs) at different times to assess readiness for extubation

28 days

Daily monitoring in ICU

Follow-up

Participants are monitored for recovery outcomes such as ICU stay, hospital discharge, and reintubation rates

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Later Morning Timing of Spontaneous Breathing Trials

Trial Overview

The study is testing whether conducting Spontaneous Breathing Trials (SBTs) early in the morning or later in the morning leads to better outcomes for patients needing ventilator support in the ICU.

How Is the Trial Designed?

Group I: Later morning timing of spontaneous breathing trial Experimental Treatment 1 Intervention

Later 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.

Group II: Early morning timing of spontaneous breathing trial Active Control 1 Intervention

Early Morning Group: Patients in this group will undergo their SBTs between 4:00 AM and 5:00 AM, following the traditional early morning schedule used in some ICUs.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study of 40 ICU patients undergoing a 30-minute spontaneous breathing trial (SBT), breathing variables remained stable, with less than ±20% change observed by the end of the trial.

Significant detrimental changes in breathing variables were rare, occurring in less than 5% of subjects after 10 minutes, suggesting that SBTs can be safely monitored with less frequent assessments after the initial period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in breathing variables during a 30-minute spontaneous breathing trial. Figueroa-Casas, JB., Connery, SM., Montoya, R.[2015]

The CORE index, which assesses compliance, oxygenation, respiration, and effort, was found to be the most accurate predictor of success or failure in spontaneous breathing trials (SBT) among 47 mechanically ventilated patients recovering from respiratory failure.

With a sensitivity of 100% and specificity of 95%, the CORE index outperformed other indices like CROP, P(0.1), and RSBI, indicating its potential for improving patient outcomes in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a new index to predict the outcome of a spontaneous breathing trial. Delisle, S., Francoeur, M., Albert, M., et al.[2011]

In a study of 46 patients with brain injury who underwent a 30-minute spontaneous breathing trial (SBT), 37% experienced failure in ventilator liberation within 48 hours, indicating that SBT success does not guarantee long-term ventilator independence.

Despite successful SBTs, the physiological parameters measured (like respiratory rate and diaphragm activity) did not effectively predict which patients would ultimately succeed in being liberated from mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of a successful spontaneous breathing trial in ventilator liberation in brain-injured patients. Shi, ZH., Jonkman, AH., Tuinman, PR., et al.[2023]

In a meta-analysis of nine randomized controlled trials involving 3115 participants, a 30-minute Pressure Support Ventilation (PSV) was found to be the most effective strategy for successfully liberating patients from mechanical ventilation during spontaneous breathing trials (SBTs).

While 30-minute PSV showed the highest success rate, both 120-minute T-piece and 120-minute PSV strategies were associated with lower reintubation rates, indicating that longer durations may benefit patients at higher risk of needing to be reintubated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of pressure support ventilation and T-piece in differing duration among weaning patients: A systematic review and network meta-analysis. Ye, X., Waters, D., Yu, HJ.[2023]

In a study of 20 critically ill trauma patients, the combination of sedation wake-up trials (SWT) and spontaneous breathing trials (SBT) was successfully implemented, with 67% of SWT attempts passing and over half of the patients being able to discontinue mechanical ventilation after SBT.

Physiological responses such as heart rate, respiratory rate, and systolic blood pressure increased significantly during SWT, but the overall mean increase was less than 20%, indicating that the procedure was well tolerated and safe without needing to stop continuous analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a sedation wake-up trial and spontaneous breathing trial in critically ill trauma patients: a secondary analysis. Figueroa-Ramos, MI., Arroyo-Novoa, CM., Padilla, G., et al.[2016]

In a study of 523 critically ill children in a pediatric ICU, a 1-hour spontaneous breathing trial (SBT) showed similar extubation failure rates compared to a 2-hour SBT, suggesting that shorter trials may be just as effective.

The 1-hour SBT had a significantly higher pass rate (71.4%) compared to the 2-hour SBT (51.1%), indicating that shorter trials may lead to more successful extubation outcomes while potentially reducing the duration of invasive ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Ventilator Liberation: One-Hour Versus Two-Hour Spontaneous Breathing Trials in a Single Center. Loberger, JM., Watson, CR., Clingan, EM., et al.[2023]

In a study involving 470 critically ill patients, reconnecting to mechanical ventilation for 1 hour after a successful spontaneous breathing trial significantly reduced the need for reintubation within 48 hours, with only 5% of patients in the rest group needing reintubation compared to 14% in the control group.

The study suggests that allowing patients a brief period of rest on mechanical ventilation after a successful breathing trial can improve outcomes, highlighting the importance of recovery time in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reconnection to mechanical ventilation for 1 h after a successful spontaneous breathing trial reduces reintubation in critically ill patients: a multicenter randomized controlled trial. Fernandez, MM., González-Castro, A., Magret, M., et al.[2020]

A survey of 135 clinicians in three ICUs revealed that 80% believe the process of spontaneous breathing trials (SBTs) and extubation takes too long, negatively impacting patient outcomes.

Key factors contributing to delays in extubation after successful SBTs include timing of SBTs, low clinician confidence in making extubation decisions, and patient-specific issues, suggesting that addressing these barriers could improve mechanical ventilation liberation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Perceived Barriers and Facilitators to Timely Extubation of Critically Ill Adults: An Interprofessional Survey. Balas, MC., Tate, J., Tan, A., et al.[2022]

Implementing a mandatory daily spontaneous-breathing trial (SBT) protocol in an ICU improved extubation rates from 27% to 42% over a year, indicating enhanced readiness for discontinuation of mechanical ventilation.

The reintubation rate remained stable at around 6-8%, suggesting that the increased extubation rates did not compromise patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved extubation rates and earlier liberation from mechanical ventilation with implementation of a daily spontaneous-breathing trial protocol. Robertson, TE., Sona, C., Schallom, L., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4893753/

Ventilator Weaning and Spontaneous Breathing Trials

Spontaneous breathing trial (SBT) assesses the patient's ability to breathe while receiving minimal or no ventilator support.

2.

withpower.com

withpower.com/trial/phase-weaning-8-2024-c54bb

Timing of Breathing Tests for Patients on Ventilators

Research shows that implementing a daily spontaneous-breathing trial (SBT) protocol can improve extubation rates and help patients come off ventilators sooner.

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0147956324002000

Short vs Long Spontaneous Breathing Trial for Difficult Weaning

Hence, we conducted this study comparing short (30 min) and long (120 min) SBTs among patients who failed their initial SBT. By identifying the optimal strategy ...

4.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2209041

Spontaneous Breathing Trials: Pressure Support vs. T-Piece

Outcomes. The primary outcome was the total time alive and without exposure to invasive mechanical ventilation (reported as the number of ventilator-free days) ...

5.

medinform.jmir.org

medinform.jmir.org/2025/1/e64592

Deep Learning Predicts Spontaneous Breathing Trial Outcome

Through this model, we aim to enhance the accuracy and efficiency of ventilator weaning assessments, reduce unnecessary SBT attempts, optimize ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11285503/

AARC Clinical Practice Guideline: Spontaneous Breathing ...

Both studies found worse outcomes with SIMV weaning, which delayed liberation from mechanical ventilation.

7.

ahrq.gov

ahrq.gov/hai/tools/mvp/modules/technical/sat-sbt-lit-review.html

Spontaneous Awakening Trials and ...

Study findings show that weaning by gradual pressure support (PS) without an initial SBT was associated with better outcomes (in terms of higher weaning trial ...

8.

chestcc.org

chestcc.org/article/S2949-7884(24)00039-X/fulltext

Improving Spontaneous Breathing Trials With a ...

This quality improvement (QI) project aimed to standardize and re-establish RT-driven protocol for screening patients for SBT readiness and administering SBTs ...

9.

aarc.org

aarc.org/wp-content/uploads/2023/11/CPG2024SpontaneousBreathingTrial.pdf

Spontaneous Breathing Trials for Liberation From Adult ...

Esteban et al2 reported that once-daily SBTs led to earlier ventilator liberation than SIMV or PSV weaning, but their RCT found no significant ...