Optimal Timing for Spontaneous Breathing Trials

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiration, Artificial; Weaning
• Intervention / Treatment: Other: Later Morning Timing of Spontaneous Breathing Trials

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 348
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Li, PhD; Phone Number: 3125634643; Email: jie_li@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Jie Li, PhD; Phone Number: 3125634643; Email: jie_li@rush.edu
      • Sub-Investigator: Lingyue Gong, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the end of study at 28 days
ICU and Hospital Mortality	This outcome records the percentage of patients who die while in the ICU or during their overall hospital stay.	From enrollment to the end of study at 28 days
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.	From enrollment to the end of study at 28 days
Reintubation Rates	This outcome measures the percentage of patients who require reintubation within 48 hours of being extubated.	From enrollment to the end of study at 28 days
Tracheostomy Rates	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.	From enrollment to the end of study at 28 days

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: JIE LI, PhD, Rush University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 17, 2024
• First Submitted That Met QC Criteria: August 18, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Weaning; Spontaneous breathing trial; Mechanical ventilation duration
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Pathological Conditions, Signs and Symptoms; Respiratory Aspiration
• Other Study ID Numbers: 24081701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to institution rule

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No