Recruiting

Observational Study

Sponsor:

Rush University Medical Center

Code:

NCT06561295

Conditions

Respiration, Artificial

Weaning

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Later Morning Timing of Spontaneous Breathing Trials

Study Details

Brief summary:

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.

Conditions

Respiration, Artificial

Weaning

Study ID

NCT06561295

Start date

Sep 17, 2024

Status verified date

Sep, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

348 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Early morning timing of spontaneous breathing trial

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.

experimental: Later morning timing of spontaneous breathing trial

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.

Interventions

Later Morning Timing of Spontaneous Breathing Trials

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 outcome measure

  • mechanical ventilation duration [ Time Frame: From enrollment to the end of study at 28 days ]

Central Contacts and Locations

Central contacts

JIE LI, PhD

3125634643jie_li@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Jie Li, PhD

3125634643jie_li@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • Spontaneous breathing trial
  • Weaning
  • Mechanical ventilation duration

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-09-30.