Respiration, ArtificialNCT06561295
Optimal Timing for Spontaneous Breathing Trials
A study testing Later Morning Timing of Spontaneous Breathing Trials in people with Respiration, Artificial and Weaning, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Respiration, Artificial, Weaning
- What is being tested?
- Later Morning Timing of Spontaneous Breathing Trials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients intubated at other hospitals.
- Patients intubated for surgical or interventional procedures.
- Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO).
- Patients with a tracheostomy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Jie Li, PhD, 312-563-4643, jie_li@rush.edu
Lingyue Gong, MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Respiration, Artificial, Weaning
- Being tested
- Later Morning Timing of Spontaneous Breathing Trials
- Keywords
- Spontaneous breathing trial, Weaning, Mechanical ventilation duration
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Later Morning Timing of Spontaneous Breathing TrialsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Later Morning Timing of Spontaneous Breathing Trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of study at 28 days
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of study at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start17 Sep 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, Rush University Medical Center
- Investigators
- JIE LI, PhD, Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561295
- Sponsor's protocol ID
- 24081701
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to institution rule
Publications
Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114.
PubMed 37402584Jung 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.
PubMed 33104823Ouellette 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.
PubMed 27818331Roberts 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.
PubMed 38443142
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spontaneous Breathing Trial Timing on Outcomes in Mechanically Ventilated Adult Patients
- ClinicalTrials.gov ID
- NCT06561295
- Acronym / sponsor ID
- 24081701
- Conditions
- Respiration, Artificial, Weaning
- Keywords
- Spontaneous breathing trial, Weaning, Mechanical ventilation duration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Later Morning Timing of Spontaneous Breathing TrialsLater 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients intubated at other hospitals.
- Patients intubated for surgical or interventional procedures.
- Patients receiving venovenous extracorporeal membrane oxygenation (VV-ECMO).
- Patients with a tracheostomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Later Morning Timing of Spontaneous Breathing TrialsLater 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 trial |
Primary outcome
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.
5 secondary outcomes
Duration Between SBT Success and Extubation
Time frame: From enrollment to the end of study at 28 days
ICU and Hospital Mortality
Time frame: From enrollment to the end of study at 28 days
ICU and Hospital Lengths of Stay
Time frame: From enrollment to the end of study at 28 days
Reintubation Rates
Time frame: From enrollment to the end of study at 28 days
Tracheostomy Rates
Time frame: From enrollment to the end of study at 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 37402584Roberts KJ. 2022 Year in Review: Ventilator Liberation. Respir Care. 2023 Nov 25;68(12):1728-1735. doi: 10.4187/respcare.11114.
- Background: PubMed 33104823Jung 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.
- Background: PubMed 27818331Ouellette 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.
- Background: PubMed 38443142Roberts 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.
- Individual participant dataSharing planned: No. Due to institution rule
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JIE LI, PhD principal investigator
Rush University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Later Morning Timing of Spontaneous Breathing Trials in people with Respiration, Artificial and Weaning, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JIE LI, PhD (3125634643, jie_li@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanical ventilation duration (time frame: From enrollment to the end of study at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561295, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.