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NCT Number: NCT06561295

Optimal Timing for Spontaneous Breathing Trials

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.

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Key information

Conditions

Respiration, Artificial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Weaning

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Jie Li, PhD

CONTACT

[email protected]

3125634643

Lingyue Gong, MS

SUB_INVESTIGATOR

About this study

This study seeks to understand how the timing of Spontaneous Breathing Trials (SBTs) impacts the recovery of adult patients who are on mechanical ventilation in the Intensive Care Unit (ICU). Mechanical ventilation is a life-support technique used for patients who are unable to breathe on their own. The Spontaneous Breathing Trial is a key step in assessing whether a patient is ready to breathe independently and can safely have the ventilator removed.

Currently, there is no universal standard for the best time of day to conduct these trials. Some hospitals perform SBTs early in the morning, while others wait until later in the morning when more staff are available. This study will compare two groups of patients: one group will have their SBTs early in the morning, and the other group will have them later.

The primary goal is to determine whether the timing of these trials affects how long patients need mechanical ventilation, how quickly they can be safely extubated (removal of the breathing tube), and overall recovery outcomes, such as ICU stay and hospital discharge.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients intubated at other hospitals.
  • Patients intubated for surgical or interventional procedures.
  • Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO).
  • Patients with a tracheostomy.

Treatment and study plan

Later Morning Timing of Spontaneous Breathing Trials

Other

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.

Primary outcomes

  1. mechanical ventilation duration

    Time frame: From enrollment to the end of study at 28 days

    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.

Secondary outcomes

  1. Duration Between SBT Success and Extubation

    Time frame: From enrollment to the end of study at 28 days

    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.

  2. ICU and Hospital Mortality

    Time frame: From enrollment to the end of study at 28 days

    This outcome records the percentage of patients who die while in the ICU or during their overall hospital stay.

  3. ICU and Hospital Lengths of Stay

    Time frame: From enrollment to the end of study at 28 days

    This outcome measures the total number of days a patient remains in the ICU and the hospital from admission to discharge.

  4. Reintubation Rates

    Time frame: From enrollment to the end of study at 28 days

    This outcome measures the percentage of patients who require reintubation within 48 hours of being extubated.

  5. Tracheostomy Rates

    Time frame: From enrollment to the end of study at 28 days

    This outcome records how often tracheostomy procedures are performed on patients who are unable to be weaned from mechanical ventilation via SBTs. A tracheostomy is a surgical procedure to create an opening through the neck into the trachea for long-term ventilatory support.

Study contacts

Contact information is provided by the study sponsor or research team.

JIE LI, PhD

CONTACT

[email protected]

3125634643

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

Impact of Spontaneous Breathing Trial Timing on Outcomes in Mechanically Ventilated Adult Patients

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 20, 2024
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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