Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

Not Applicable

Completed

• Conditions: Mechanical Ventilation Complication; Ventilator-Induced Lung Injury; Acute Respiratory Failure
• Interventions: Device: Viasys Avea Ventilator; Device: Philips Respironics NM3 device; Device: Servo U ventilator; Device: Vyaire SmartCath adult nasogastric tube with Esophageal balloon

• Registration Number: NCT05125952
• Lead Sponsor: Duke University

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-18
• Study Start: 2022-02-08
• Status Verified: 2023-11
• Primary Completion: 2023-11-21
• Study Completion: 2023-12-21
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Adult patients age ≥18 years with acute respiratory failure receiving invasive mechanical ventilation
• Managed in pressure-support mode of ventilation

Exclusion Criteria

• Actively undergoing a spontaneously awakening trial or SAT
• Patient or surrogate is unable to provide informed consent
• Currently pregnant
• Currently incarcerated
• Acute exacerbation of an obstructive lung disease
• Known esophageal varices or any other condition for which the attending physician deems an orogastric catheter to be unsafe
• Esophageal, gastric or duodenal surgical procedures within the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute Respiratory Failure	Philips Respironics NM3 device	Patients with acute respiratory failure managed with pressure-support ventilation.
Acute Respiratory Failure	Servo U ventilator	Patients with acute respiratory failure managed with pressure-support ventilation.
Acute Respiratory Failure	Viasys Avea Ventilator	Patients with acute respiratory failure managed with pressure-support ventilation.
Acute Respiratory Failure	Vyaire SmartCath adult nasogastric tube with Esophageal balloon	Patients with acute respiratory failure managed with pressure-support ventilation.

Primary Outcome Measures

Name	Time	Method
Respiratory System Driving Pressure measure by Respironics NM3 device (DPrs-NM3)	Study day 1	Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Airway Occlusion Test (AOC)	Study day 1	Maximum negative airway pressure in centimeters of water during an airway occlusion maneuver.
Respiratory System Driving Pressure measured during volume control breath.	Study day 1	Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Respiratory System Driving Pressure measure by Servo Ventilator (DPrs-servo)	Study day 1	Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Transpulmonary Driving pressure measured during volume control breath.	Study day 1	Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.

Secondary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	Index hospitalization (up to 28 days)	Number of days receiving mechanical ventilation
Duration of intensive care unit admission	Index hospitalization (up to 28 days)	Number of days admitted to intensive care unit
In-hospital survival	Index hospitalization (up to 28 days)	Survival to discharge
Duration of hospital admission	Index hospitalization (up to 28 days)	Number of days admitted to hospital
Ventilator Free Days	Index hospitalization (up to 28 days)	Number of days free from mechanical ventilation

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States