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

Not Applicable

Not yet recruiting

• Conditions: Spontaneous Breathing Trial in ICU

• Registration Number: NCT07005505
• Lead Sponsor: Rush University Medical Center

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.

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study Start: 2025-06-01
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 880

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Reintubation	Within 48 hours of extubation
Death	Within 48 hours of extubation

Secondary Outcome Measures

Name	Time	Method
Ventilator associated complications	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
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.	The duration (in hours) from the spontaneous breathing trial (SBT) initiation to extubation without reintubation within 48 hours
Spontaneous breathing trial (SBT) results	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
Reintubation	Within 7 days of extubation
Use of noninvasive respiratory support	Within 48 hours of extubation	Use of noninvasive ventilation, continuous positive airway pressure (CPAP), and high flow nasal cannula (HFNC) and its duration
Total duration of mechanical ventilation	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)	From the date of ICU admission to the date of ICU discharge, assessed up to 30 days.
Hospital length of stay (LOS)	From the date of hospital admission to the date of hospital discharge, assessed up to 30 days.
Mortality	Up to 30 days
Clinician adherence to initially assigned spontaneous breathing trial (SBT) mode	Up to 30 days