Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
Conditions
Keywords
Self-induced lung injury, Pressure-support ventilation
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.
Interventions
DEVICEPhilips Respironics NM3 device
Measuring static airway driving pressure during pressure support breath
DEVICEServo U ventilator
Measuring static airway driving pressure and p0.1 during pressure support breath.
DEVICEVyaire 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.
DEVICEViasys 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.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. The Vyaire SmartCath adult nasogastric tube with esophageal balloon was used to measure esophogeal pressure change during 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| In-hospital Survival | Index hospitalization (up to 28 days) | Survival to discharge |
Countries
United States
Participant flow
Pre-assignment details
Participants were randomized to different sequences of receiving the 4 different measurement methods: Viasys Avea Ventilator, Philips Respironics NM3 device, Servo U ventilator, and Vyaire SmartCath adult nasogastric tube with Esophageal balloon.
Participants by arm
| Arm | Count |
|---|---|
| Acute Respiratory Failure Patients with acute respiratory failure managed with pressure-support ventilation.
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.
Philips Respironics NM3 device: Measuring static airway driving pressure during pressure support breath
Servo U ventilator: Measuring static airway driving pressure and p0.1 during pressure support breath.
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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Acute Respiratory Failure |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 63 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 8 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
Airway Occlusion Test (AOC)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Airway Occlusion Test (AOC) | 17.4 centimeters of water | Standard Deviation 10.1 |
Primary
Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3)
Driving pressure in centimeters of water measured with Phillips Respironics NM3 device in pressure-support ventilation.
Time frame: Study day 1
Population: Not measured in 6 patients after Philips announced discontinuation of support for NM3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Respiratory System Driving Pressure Measure by Respironics NM3 Device (DPrs-NM3) | 8.8 centimeters of water | Standard Deviation 3.2 |
Primary
Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo)
Driving pressure in centimeters of water measured with inspiratory hold on Servo Ventilator in pressure-support ventilation.
Time frame: Study day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Respiratory System Driving Pressure Measure by Servo Ventilator (DPrs-servo) | 12.3 centimeters of water | Standard Deviation 2.9 |
Primary
Respiratory System Driving Pressure Measured During Volume Control Breath.
Airway driving pressure in centimeters of water measured with inspiratory hold in volume control/assist control.
Time frame: Study day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Respiratory System Driving Pressure Measured During Volume Control Breath. | 12.3 centimeters of water | Standard Deviation 3.4 |
Primary
Transpulmonary Driving Pressure Measured During Volume Control Breath.
Transpulmonary driving pressure in centimeters of water measured via esophageal balloon with inspiratory hold in volume control/assist control.
Time frame: Study day 1
Population: Not measured in 7 patients who could not have esophageal balloon placed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Transpulmonary Driving Pressure Measured During Volume Control Breath. | 9.5 centimeters of water | Standard Deviation 3.6 |
Secondary
Duration of Hospital Admission
Number of days admitted to hospital
Time frame: Index hospitalization (up to 28 days)
Population: Not measured in 8 patients who did not survive to hospital discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Duration of Hospital Admission | 28 days | Standard Deviation 0.8 |
Secondary
Duration of Intensive Care Unit Admission
Number of days admitted to intensive care unit
Time frame: Index hospitalization (up to 28 days)
Population: Not measured for 5 patients who did not survive to ICU discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Duration of Intensive Care Unit Admission | 17.2 days | Standard Deviation 6.9 |
Secondary
Duration of Mechanical Ventilation
Number of days receiving mechanical ventilation
Time frame: Index hospitalization (up to 28 days)
Population: Not measured in 3 patients who were never extubated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Respiratory Failure | Duration of Mechanical Ventilation | 12.4 days | Standard Deviation 9.1 |
Secondary
In-hospital Survival
Survival to discharge
Time frame: Index hospitalization (up to 28 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Respiratory Failure | In-hospital Survival | 7 Participants |
Secondary
Ventilator Free Days
Number of days free from mechanical ventilation
Time frame: Index hospitalization (up to 28 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acute Respiratory Failure | Ventilator Free Days | 16 days |