Rush University Medical Center
Chicago, Illinois, 60612, United States
Location status: Recruiting
Location contact
Jie Li, PhD
CONTACT
Lauren Harnois, MS
CONTACT
Lauren Harnois, MS
SUB_INVESTIGATOR
NCT Number: NCT07005505
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Location status: Recruiting
Jie Li, PhD
CONTACT
Lauren Harnois, MS
CONTACT
Lauren Harnois, MS
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Within 48 hours of extubation
Time frame: Within 48 hours of 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
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
Time frame: within 24 hours of extubation
Time frame: Within 72 hours of extubation
Time frame: Within 7 days of extubation
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
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.
Time frame: From the date of ICU admission to the date of ICU discharge, assessed up to 30 days.
Time frame: From the date of hospital admission to the date of hospital discharge, assessed up to 30 days.
Time frame: At intensive care unit (ICU) discharge
Time frame: Up to 30 days
Time frame: Up to 30 days
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
Contact information is provided by the study sponsor or research team.
Rush University Medical Center
Other
Automatic Tube Compensation vs. Pressure Support Ventilation During Spontaneous Breathing Trials in Critically Ill Adults: A Cluster-Randomized, Cluster-Crossover Trial
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.
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