Assessing Ventilator Safety in Patients on Pressure-Support Ventilation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2023-12-21

Brief Summary

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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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Detailed Description

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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

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Acute Respiratory Failure Mechanical Ventilation Complication Ventilator-Induced Lung Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Acute Respiratory Failure

Patients with acute respiratory failure managed with pressure-support ventilation.

Group Type EXPERIMENTAL

Viasys Avea Ventilator

Intervention Type DEVICE

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.

Philips Respironics NM3 device

Intervention Type DEVICE

Measuring static airway driving pressure during pressure support breath

Servo U ventilator

Intervention Type DEVICE

Measuring static airway driving pressure and p0.1 during pressure support breath.

Vyaire SmartCath adult nasogastric tube with Esophageal balloon

Intervention Type DEVICE

Measuring static and dynamic esophageal driving pressure during pressure support breath, and esophogeal pressure change during airway occlusion maneuver.

Interventions

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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.

Intervention Type DEVICE

Philips Respironics NM3 device

Measuring static airway driving pressure during pressure support breath

Intervention Type DEVICE

Servo U ventilator

Measuring static airway driving pressure and p0.1 during pressure support breath.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No