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

NCT ID: NCT07005505

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spontaneous Breathing Trial in ICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Adult Intensive Care Unit (AICU)

Group Type EXPERIMENTAL

Pressure Support Ventilation (PSV)

Intervention Type 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)

Intervention Type 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.

Medical Intensive Care Unit (MICU)

Group Type EXPERIMENTAL

Pressure Support Ventilation (PSV)

Intervention Type 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)

Intervention Type 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.

Cardiosciences Intensive Care Unit (CSICU)

Group Type EXPERIMENTAL

Pressure Support Ventilation (PSV)

Intervention Type 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)

Intervention Type 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.

Neuroscience Intensive Care Unit (NSICU)

Group Type EXPERIMENTAL

Pressure Support Ventilation (PSV)

Intervention Type 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)

Intervention Type 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.

Interventions

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Pressure Support Ventilation (PSV)

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.

Intervention Type OTHER

Automatic tube compensation (ATC)

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Clinical decision made not to proceed with extubation regardless of spontaneous breathing trial (SBT) results
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jie Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jie Li, PhD

Role: CONTACT

[email protected]
312-563-4643

Lauren Harnois, MSc

Role: CONTACT

[email protected]

Facility Contacts

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Jie Li, PhD

Role: primary

[email protected]
3125634643

Lauren Harnois, MS

Role: backup

[email protected]

References

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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.

Reference Type BACKGROUND
PMID: 37957759 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39526662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39444919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31836913 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 12190798 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19236688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36137582 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12029248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39382222 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38849936 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38393729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38443142 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31690615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17470624 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 37402584 (View on PubMed)

Trudzinski FC, Neetz B, Bornitz F, Muller M, Weis A, Kronsteiner D, Herth FJF, Sturm N, Gassmann V, Frerk T, Neurohr C, Ghiani A, Joves B, Schneider A, Szecsenyi J, von Schumann S, Meis J. Risk Factors for Prolonged Mechanical Ventilation and Weaning Failure: A Systematic Review. Respiration. 2022;101(10):959-969. doi: 10.1159/000525604. Epub 2022 Aug 17.

Reference Type BACKGROUND
PMID: 35977525 (View on PubMed)

Other Identifiers

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25031208

Identifier Type: -

Identifier Source: org_study_id

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