NCT05125952

Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Respiratory Failure
• Mechanical Ventilation Complication
• Ventilator-Induced Lung Injury

Interventions

Type	Name	Description
DEVICE	Viasys Avea Ventilator	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.
DEVICE	Philips Respironics NM3 device	Measuring static airway driving pressure during pressure support breath
DEVICE	Servo U ventilator	Measuring static airway driving pressure and p0.1 during pressure support breath.
DEVICE	Vyaire SmartCath adult nasogastric tube with Esophageal balloon	Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.

Timeline

• Start date: 2022-02-08
• Primary completion: 2023-11-21
• Completion: 2023-12-21
• First posted: 2021-11-18
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study