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Spontaneous Breathing Trial in ICUNCT07005505

Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Adults

A study testing Pressure Support Ventilation (PSV) and Automatic tube compensation (ATC) in people with Spontaneous Breathing Trial in ICU, run by Rush University Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

For patients requiring mechanical ventilation, spontaneous breathing trials (SBTs) are conducted to determine if it is safe to remove the breathing tube. There are multiple methods for conducting SBTs. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spontaneous Breathing Trial in ICU
What is being tested?
Pressure Support Ventilation (PSV) and Automatic tube compensation (ATC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
880 participants
Where
1 siteUnited States
Study dates
1 Jun 2025to Aug 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Admitted to intensive care unit (ICU)
  • Age 18 years or older
  • Requiring invasive mechanical ventilation for at least 24 hours
  • Pass spontaneous breathing trial screen criteria

Who cannot join

  • Do not intubate (DNI) order
  • Presence of tracheostomy
  • Pregnancy
  • Known prisoner
  • Immediate need for extubation, self-extubation, or unplanned extubation that precludes safe performance of study procedures
  • Enrolled in another clinical trial that impacts ventilator weaning or liberation
  • Receive veno-venous extracorporeal membrane oxygenation (VV-ECMO)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jie Li, PhD contact

312-563-4643

Jie_Li@rush.edu

Lauren Harnois, MSc contact

Lauren_J_Harnois@rush.edu

United States1 site, 1 recruiting
  • Rush University Medical Center

    Chicago, Illinois, 60612

    Jie Li, PhD, 3125634643, jie_li@rush.edu

    Lauren Harnois, MS, Lauren_J_Harnois@rush.edu

    Recruiting

Other trials in United States

About this study

Official title: Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Critically Ill Adults: A Cluster-Randomized, Cluster-Crossover Trial

For patients requiring mechanical ventilation, spontaneous breathing trials (SBTs) are conducted to determine if it is safe to remove the breathing tube. There are multiple methods for conducting SBTs. The purpose of this study is to compare the effects of 2 methods, pressure support ventilation (PSV) versus automatic tube compensation (ATC), on successful extubation for critically ill adult patients who received mechanical ventilation for over 24 hours.

Read the detailed description

The delivery of pressure support through the ventilator can be fixed using the pressure support ventilation (PSV) mode or variable using the automatic tube compensation (ATC) mode. Similar to PSV, ATC provides pressure support but dynamically adjusts it to compensate the resistive work of breathing and the mechanical load on respiratory muscles imposed by an artificial airway, such as an endotracheal or tracheostomy tube. Although both ATC and PSV are licensed and used in clinical practice, the optimal method to deliver pressure support during a spontaneous breathing trial (SBT) remains unknown. At Rush University Medical Center, ATC has been used for SBTs for over a decade. However, given the growing popularity of PSV, the SBT protocol was updated and now approves the use of PSV and ATC as standard care for SBT without making a recommendation for a preferred mode. The choice between PSV and ATC during SBT is left to the discretion of the clinician, reflecting the ongoing equipoise in the conduct of the SBT. As patients will be exposed to the potential benefits and risks of PSV or ATC under this change in clinical practice, the investigators are conducting a cluster-randomized cluster-crossover trial to compare the mode's effect on successful extubation.

Being tested
Pressure Support Ventilation (PSV), Automatic tube compensation (ATC)
Keywords
Ventilator liberation, Spontaneous breathing trial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pressure Support Ventilation (PSV)Other

    Spontaneous breathing trials will be conducted using the mode pressure support ventilation (PSV) with settings of a pressure support of 5 cmH2O and positive end expiratory pressure (PEEP) 5 cmH2O.

  • Automatic tube compensation (ATC)Other

    Spontaneous breathing trials will be conducted using the mode automatic tube compensation (ATC) with settings of 100% tube compensation and a positive end expiratory pressure (PEEP) of 5 cmH2O.

Study groups in NCT07005505
Study groupRoleWhat they receive
Adult Intensive Care Unit (AICU)ExperimentalNot described
Receives: Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)
Medical Intensive Care Unit (MICU)ExperimentalNot described
Receives: Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)
Cardiosciences Intensive Care Unit (CSICU)ExperimentalNot described
Receives: Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)
Neuroscience Intensive Care Unit (NSICU)ExperimentalNot described
Receives: Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reintubation, continued invasive mechanical ventilation, or death

    Measured: 48 hours after receiving the first SBT

Secondary outcomes (1)
  1. Time to successful extubation

    The duration (in hours) from the first spontaneous breathing trial (SBT) initiation to extubation without reintubation within 48 hours

    Measured: From the start of the first spontaneous breathing trial (SBT) to the first successful extubation (without reintubation within 48 hours) or death from any cause, whichever occurred first, assessed up to 30 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start1 Jun 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

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
Randomised
Intervention model
Crossover
Model description
During the first month of the study, each intensive care unit (ICU) will be randomly assigned to one mode of spontaneous breathing trial (SBT). Each month thereafter, each ICU will independently alternate between the two modes. Patients will be analyzed based on the group to which they were assigned at enrollment (intention-to-treat), even if they remain in the study ICU during a transition from one month to the next or transfer to another ICU assigned to the opposite SBT mode ("crossover"). The last three days of each month will serve as an analytic washout period, during which the study ICU will continue using the assigned ventilator mode, but new patients will not be included in the primary analysis. This three-day washout period is intended to minimize the number of patients experiencing a "crossover" between assigned modes within the 72-hour timeframe used to assess feasibility outcomes and adherence.
Masking
Single blind
Who is masked
Participant
Enrolment
880 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07005505
Sponsor's protocol ID
25031208
Status last verified
Oct 2026
First submitted
19 May 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Latronico N, Rasulo FA, Eikermann M, Piva S. Illness Weakness, Polyneuropathy and Myopathy: Diagnosis, treatment, and long-term outcomes. Crit Care. 2023 Nov 13;27(1):439. doi: 10.1186/s13054-023-04676-3.

    PubMed 37957759
  • Hoshino T, Yoshida T. Spontaneous breathing-induced lung injury in mechanically ventilated patients. Curr Opin Crit Care. 2025 Feb 1;31(1):5-11. doi: 10.1097/MCC.0000000000001231. Epub 2024 Nov 8.

    PubMed 39526662
  • Li W, Cai J, Ding L, Chen Y, Wang X, Xu H. Incidence and risk factors of ventilator-associated pneumonia in the intensive care unit: a systematic review and meta-analysis. J Thorac Dis. 2024 Sep 30;16(9):5518-5528. doi: 10.21037/jtd-24-150. Epub 2024 Sep 14.

    PubMed 39444919
  • Guerin C, Terzi N, Mezidi M, Baboi L, Chebib N, Yonis H, Argaud L, Heunks L, Louis B. Low-pressure support vs automatic tube compensation during spontaneous breathing trial for weaning. Ann Intensive Care. 2019 Dec 13;9(1):137. doi: 10.1186/s13613-019-0611-y.

    PubMed 31836913
  • El-Shahat, H., Salama, S., Wafy, S. et al. Automatic tube compensation versus pressure support ventilation as a weaning mode: does it make a difference?. Egypt J Bronchol 9, 253-260 (2015). https://doi.org/10.4103/1687-8426.165905

  • Haberthur C, Mols G, Elsasser S, Bingisser R, Stocker R, Guttmann J. Extubation after breathing trials with automatic tube compensation, T-tube, or pressure support ventilation. Acta Anaesthesiol Scand. 2002 Sep;46(8):973-9. doi: 10.1034/j.1399-6576.2002.460808.x.

    PubMed 12190798
  • Cohen J, Shapiro M, Grozovski E, Fox B, Lev S, Singer P. Prediction of extubation outcome: a randomised, controlled trial with automatic tube compensation vs. pressure support ventilation. Crit Care. 2009;13(1):R21. doi: 10.1186/cc7724. Epub 2009 Feb 23.

    PubMed 19236688
  • Cardinal-Fernandez P, Bougnaud J, Cour M, Argaud L, Poole D, Guerin C. Automatic Tube Compensation During Spontaneous Breathing Trials. Respir Care. 2022 Oct;67(10):1335-1342. doi: 10.4187/respcare.09920. Epub 2022 Jun 21.

    PubMed 36137582
  • Guttmann J, Haberthur C, Mols G, Lichtwarck-Aschoff M. Automatic tube compensation (ATC). Minerva Anestesiol. 2002 May;68(5):369-77.

    PubMed 12029248
  • Burns KEA, Wong J, Rizvi L, Lafreniere-Roula M, Thorpe K, Devlin JW, Cook DJ, Seely A, Dodek PM, Tanios M, Piraino T, Gouskos A, Kiedrowski KC, Kay P, Mitchell S, Merner GW, Mayette M, D'Aragon F, Lamontagne F, Rochwerg B, Turgeon A, Sia YT, Charbonney E, Aslanian P, Criner GJ, Hyzy RC, Beitler JR, Kassis EB, Kutsogiannis DJ, Meade MO, Liebler J, Iyer-Kumar S, Tsang J, Cirone R, Shanholtz C, Hill NS; Canadian Critical Care Trials Group. Frequency of Screening and Spontaneous Breathing Trial Techniques: A Randomized Clinical Trial. JAMA. 2024 Dec 3;332(21):1808-1821. doi: 10.1001/jama.2024.20631.

    PubMed 39382222
  • Burns KEA, Sadeghirad B, Ghadimi M, Khan J, Phoophiboon V, Trivedi V, Gomez Builes C, Giammarioli B, Lewis K, Chaudhuri D, Desai K, Friedrich JO. Comparative effectiveness of alternative spontaneous breathing trial techniques: a systematic review and network meta-analysis of randomized trials. Crit Care. 2024 Jun 8;28(1):194. doi: 10.1186/s13054-024-04958-4.

    PubMed 38849936
  • Burns KEA, Khan J, Phoophiboon V, Trivedi V, Gomez-Builes JC, Giammarioli B, Lewis K, Chaudhuri D, Desai K, Friedrich JO. Spontaneous Breathing Trial Techniques for Extubating Adults and Children Who Are Critically Ill: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2024 Feb 5;7(2):e2356794. doi: 10.1001/jamanetworkopen.2023.56794.

    PubMed 38393729
  • 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.

    PubMed 38443142
  • Mart MF, Brummel NE, Ely EW. The ABCDEF Bundle for the Respiratory Therapist. Respir Care. 2019 Dec;64(12):1561-1573. doi: 10.4187/respcare.07235. Epub 2019 Nov 5.

    PubMed 31690615
  • Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.

    PubMed 17470624

Questions about this trial

What is this clinical trial studying?

A study testing Pressure Support Ventilation (PSV) and Automatic tube compensation (ATC) in people with Spontaneous Breathing Trial in ICU, 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 4 inclusion and 7 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 28 Oct 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 (312-563-4643, Jie_Li@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reintubation, continued invasive mechanical ventilation, or death (time frame: 48 hours after receiving the first SBT). 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 NCT07005505, which also lists 17 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 28 Oct 2026.

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