Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation

Intermountain Health Care, Inc.

Status and phase: Unknown; Phase 2

Conditions: Respiratory Failure; Acute Respiratory Distress Syndrome (ARDS); Acute Lung Injury (ALI)

Treatments: Device: Mechanical Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT01339533

APRV1015758

Details and patient eligibility

About

APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU stay in patients with respiratory failure. APRV will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.

Full description

This prospective un-blinded randomized trial will follow patients with respiratory failure and ALI/ARDS who require invasive mechanical ventilation in select ICUs. Patients will be allocated to respiratory support with either APRV mode or volume control (AC) mode of mechanical ventilation. Qualifying patients will be randomized by permuted block randomization within 24 hours of admission to the ICU. Identical ventilation and oxygenation thresholds will be utilized to guide titration of each ventilator protocol. Patients will remain on the assigned mode of ventilation until they are extubated and discharged from the ICU.

Procedures for treatment evaluation include daily monitoring of the Ventilator protocol in each arm. Clinical coordinator and study respiratory therapist will perform 2 daily checks of the study patients to determine compliance with the protocol and if patient meets weaning criteria. The previously published ARDS Network continuous positive airway pressure (CPAP) weaning protocol will be used for all patients enrolled.

Enrollment: 246 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypoxemic respiratory failure requiring mechanical ventilation for >24 hours.

Exclusion criteria

• Age under 18
• Severe chronic obstructive lung disease
• Patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 3 patient groups

APRV ls

Experimental group

Description:

APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.

Treatment:

Device: Mechanical Ventilation

AC/VC Conventional Ventilation

Active Comparator group

Description:

Standard volume control ventilation with the ARDS Net protocol.

Treatment:

Device: Mechanical Ventilation

APRV h

Experimental group

Description:

APRV Habashi protocol which sets Plow equal to 0.

Treatment:

Device: Mechanical Ventilation