Duke University Hospital
Durham, North Carolina, 27710, United States
NCT Number: NCT05125952
ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation. We will describe the relationship between three different assessment methods for risk of self-induced lung injury and compare them to a gold standard measurement.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
Ventilator-induced lung injury (VILI) is known to cause significant morbidity and mortality in patients with acute respiratory failure. Most studies on VILI have involved the effects of inappropriate (often excessive) mechanical ventilator settings. More recently, it has been noted that similar lung damage can be caused by large, patient generated, uncontrolled tidal volumes and driving pressures, which has been termed "self-induced lung injury," or SILI.
Pressure-support ventilation (PSV) is a common mechanical ventilation mode often used in patients with active inspiratory efforts to help reduce patient inspiratory work and improve comfort. PSV effectively allows spontaneously breathing patients to determine their breath flow-rate and breath duration, eliminating flow and cycle dyssynchrony. However, pressure support ventilation does not allow for physicians to control tidal volume or driving pressure. The risk of SILI may thus be increased with PSV.
Several different methods have been proposed to address these challenges. However, to date none of these methods have been compared to assess for concordance in their ability to indicate an increased risk of self-induced lung injury. ASOP is a prospective cohort study comparing three methods for assessing risk of self-induced lung injury in patients with acute respiratory failure being managed with pressure-support ventilation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Measuring dynamic airway driving pressure and static airway driving pressure during pressure support breath, and static airway driving pressure during a volume control breath. Measuring airway occlusion pressure during pressure support breath.
Measuring static airway driving pressure during pressure support breath
Measuring static airway driving pressure and p0.1 during pressure support breath.
Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.
Time frame: Study day 1
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Time frame: Study day 1
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Time frame: Study day 1
Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during airway occlusion maneuver.
Time frame: Study day 1
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Time frame: Study day 1
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
Time frame: Index hospitalization (up to 28 days)
Number of days receiving mechanical ventilation
Time frame: Index hospitalization (up to 28 days)
Number of days admitted to intensive care unit
Time frame: Index hospitalization (up to 28 days)
Number of days admitted to hospital
Time frame: Index hospitalization (up to 28 days)
Number of days free from mechanical ventilation
Time frame: Index hospitalization (up to 28 days)
Survival to discharge
Duke University
Other
Acronym: ASOP
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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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