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

Official title

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

Overview

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.

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.

Interventions

• Other 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.
• 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.

Primary outcome measures

• Reintubation [Time frame: Within 48 hours of extubation]
• Death [Time frame: Within 48 hours of extubation]

Secondary outcome measures (12)

• Time to successful extubation [Time frame: 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 [Time frame: Up to 30 days from study enrollment or until hospital discharge, whichever occurs first.]
• Reintubation [Time frame: within 24 hours of extubation]
• Reintubation [Time frame: Within 72 hours of extubation]
• Reintubation [Time frame: Within 7 days of extubation]
• Use of noninvasive respiratory support [Time frame: Within 48 hours of extubation]
• Total duration of mechanical ventilation [Time frame: From the date of intubation to the date of extubation without reintubation within 28 hours or date of death from any cause, whichever occurs first, assessed up to 30 days.]
• Intensive care unit (ICU) length of stay (LOS) [Time frame: From the date of ICU admission to the date of ICU discharge, assessed up to 30 days.]
• Hospital length of stay (LOS) [Time frame: From the date of hospital admission to the date of hospital discharge, assessed up to 30 days.]
• Mortality [Time frame: At intensive care unit (ICU) discharge]
• Mortality [Time frame: Up to 30 days]
• Clinician adherence to initially assigned spontaneous breathing trial (SBT) mode [Time frame: Up to 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Other

Study locations

United States · 1 center

• Rush University Medical Center — Chicago

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 36137582

Identifiers

NCT: NCT07005505 · 25031208

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗