Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07005505

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Jie Li, PhD

CONTACT

[email protected]

3125634643

Lauren Harnois, MS

CONTACT

[email protected]

Lauren Harnois, MS

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reintubation

    Time frame: Within 48 hours of extubation

  2. Death

    Time frame: Within 48 hours of extubation

Secondary outcomes

  1. 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.

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

  2. Spontaneous breathing trial (SBT) results

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

    SBT results (pass or fail) for the first 3 attempts if conducted

  3. Reintubation

    Time frame: within 24 hours of extubation

  4. Reintubation

    Time frame: Within 72 hours of extubation

  5. Reintubation

    Time frame: Within 7 days of extubation

  6. Use of noninvasive respiratory support

    Time frame: Within 48 hours of extubation

    Use of noninvasive ventilation, continuous positive airway pressure (CPAP), and high flow nasal cannula (HFNC) and its duration

  7. 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.

  8. 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.

  9. Hospital length of stay (LOS)

    Time frame: From the date of hospital admission to the date of hospital discharge, assessed up to 30 days.

  10. Mortality

    Time frame: At intensive care unit (ICU) discharge

  11. Mortality

    Time frame: Up to 30 days

  12. Clinician adherence to initially assigned spontaneous breathing trial (SBT) mode

    Time frame: Up to 30 days

  13. Ventilator associated complications

    Time frame: From the date of intubation to the date of extubation without reintubation in 48 hours or death from any cause, whichever occurs first, assessed up to 30 days.

    Including ventilator associated pneumonia, skin pressure ulcers, and barotrauma such as pneumothorax, pneumomediastinum, or subcutaneous emphysema

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Li, PhD

CONTACT

[email protected]

312-563-4643

Lauren Harnois, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.