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

NCT07005505 | Recruiting DMC

• 1 other identifier: 25031208
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spontaneous Breathing Trial in ICU

Keywords

Ventilator liberation; Spontaneous breathing trial

Outcome Measures

Primary Outcomes (2)

• Reintubation

  Within 48 hours of extubation

• Death

  Within 48 hours of extubation

Secondary Outcomes (13)

• Time to successful extubation

  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.

• Spontaneous breathing trial (SBT) results

  Up to 30 days from study enrollment or until hospital discharge, whichever occurs first.

• Reintubation

  within 24 hours of extubation

• Reintubation

  Within 72 hours of extubation

• Reintubation

  Within 7 days of extubation

Study Arms (4)

Adult Intensive Care Unit (AICU)

EXPERIMENTAL

Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)

Medical Intensive Care Unit (MICU)

EXPERIMENTAL

Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)

Cardiosciences Intensive Care Unit (CSICU)

EXPERIMENTAL

Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)

Neuroscience Intensive Care Unit (NSICU)

EXPERIMENTAL

Other: Pressure Support Ventilation (PSV); Other: Automatic tube compensation (ATC)

Interventions

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.

Adult Intensive Care Unit (AICU); Cardiosciences Intensive Care Unit (CSICU); Medical Intensive Care Unit (MICU); Neuroscience Intensive Care Unit (NSICU)

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.

Adult Intensive Care Unit (AICU); Cardiosciences Intensive Care Unit (CSICU); Medical Intensive Care Unit (MICU); Neuroscience Intensive Care Unit (NSICU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 37957759 BACKGROUND

• 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.

  PMID: 39526662 BACKGROUND

• 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.

  PMID: 39444919 BACKGROUND

• 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.

  PMID: 31836913 BACKGROUND

• 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

  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.

  PMID: 12190798 BACKGROUND

• 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.

  PMID: 19236688 BACKGROUND

• 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.

  PMID: 36137582 BACKGROUND

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

  PMID: 12029248 BACKGROUND

• 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.

  PMID: 39382222 BACKGROUND

• 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.

  PMID: 38849936 BACKGROUND

• 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.

  PMID: 38393729 BACKGROUND

• 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.

  PMID: 38443142 BACKGROUND

• 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.

  PMID: 31690615 BACKGROUND

• 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.

  PMID: 17470624 BACKGROUND

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

  PMID: 37402584 BACKGROUND

• 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.

  PMID: 35977525 BACKGROUND

Central Study Contacts

Jie Li, PhD

CONTACT

312-563-4643; Jie_Li@rush.edu

Lauren Harnois, MSc

CONTACT

Lauren_J_Harnois@rush.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 5, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)