Clinical trial NCT06561295: Optimal Timing for Spontaneous Breathing Trials
Official title: Impact of Spontaneous Breathing Trial Timing on Outcomes in Mechanically Ventilated Adult Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiration, Artificial
Weaning
Keywords: Spontaneous breathing trial
Weaning
Mechanical ventilation duration
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 348
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: mechanical ventilation duration
timeFrame: From enrollment to the end of study at 28 days
Secondary outcomes:
measure: Duration Between SBT Success and Extubation
timeFrame: From enrollment to the end of study at 28 days
measure: ICU and Hospital Mortality
timeFrame: From enrollment to the end of study at 28 days
measure: ICU and Hospital Lengths of Stay
timeFrame: From enrollment to the end of study at 28 days
measure: Reintubation Rates
timeFrame: From enrollment to the end of study at 28 days
measure: Tracheostomy Rates
timeFrame: From enrollment to the end of study at 28 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University
name: JIE LI, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114.
citation: 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.
citation: 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.
citation: 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.