Optimal Timing for Spontaneous Breathing Trials

NCT06561295 | Recruiting

• 1 other identifier: 24081701
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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

Keywords

Spontaneous breathing trial; Weaning; Mechanical ventilation duration

Outcome Measures

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.

  From enrollment to the end of study at 28 days

Secondary Outcomes (5)

• Duration Between SBT Success and Extubation

  From enrollment to the end of study at 28 days

• ICU and Hospital Mortality

  From enrollment to the end of study at 28 days

• ICU and Hospital Lengths of Stay

  From enrollment to the end of study at 28 days

• Reintubation Rates

  From enrollment to the end of study at 28 days

• Tracheostomy Rates

  From enrollment to the end of study at 28 days

Study Arms (2)

Early morning timing of spontaneous breathing trial

NO 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.

Later morning timing of spontaneous breathing trial

EXPERIMENTAL

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.

Other: Later Morning Timing of Spontaneous Breathing Trials

Interventions

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.

Later morning timing of spontaneous breathing trial

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (4)

• Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114.

  PMID: 37402584 BACKGROUND

• Jung B, Vaschetto R, Jaber S. Ten tips to optimize weaning and extubation success in the critically ill. Intensive Care Med. 2020 Dec;46(12):2461-2463. doi: 10.1007/s00134-020-06300-2. Epub 2020 Oct 26. No abstract available.

  PMID: 33104823 BACKGROUND

• Ouellette DR, Patel S, Girard TD, Morris PE, Schmidt GA, Truwit JD, Alhazzani W, Burns SM, Epstein SK, Esteban A, Fan E, Ferrer M, Fraser GL, Gong MN, Hough CL, Mehta S, Nanchal R, Pawlik AJ, Schweickert WD, Sessler CN, Strom T, Kress JP. Liberation From Mechanical Ventilation in Critically Ill Adults: An Official American College of Chest Physicians/American Thoracic Society Clinical Practice Guideline: Inspiratory Pressure Augmentation During Spontaneous Breathing Trials, Protocols Minimizing Sedation, and Noninvasive Ventilation Immediately After Extubation. Chest. 2017 Jan;151(1):166-180. doi: 10.1016/j.chest.2016.10.036. Epub 2016 Nov 3.

  PMID: 27818331 BACKGROUND

• Roberts KJ, Goodfellow LT, Battey-Muse CM, Hoerr CA, Carreon ML, Sorg ME, Glogowski J, Girard TD, MacIntyre NR, Hess DR. AARC Clinical Practice Guideline: Spontaneous Breathing Trials for Liberation From Adult Mechanical Ventilation. Respir Care. 2024 Jun 28;69(7):891-901. doi: 10.4187/respcare.11735.

  PMID: 38443142 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• JIE LI, PhD

  Rush University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIE LI, PhD

CONTACT

3125634643; jie_li@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)