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

Phase 2

• Conditions: Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS); Respiratory Failure
• Interventions: Device: Mechanical Ventilation

• Registration Number: NCT01339533
• Lead Sponsor: Intermountain Health Care, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Study Start: 2011-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-24
• Last Update Posted: 2015-08-26
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APRV ls	Mechanical Ventilation	APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.
AC/VC Conventional Ventilation	Mechanical Ventilation	Standard volume control ventilation with the ARDS Net protocol.
APRV h	Mechanical Ventilation	APRV Habashi protocol which sets Plow equal to 0.

Primary Outcome Measures

Name	Time	Method
P/F Ratio on Day 3 of Mechanical Ventilation	Day 3	Our first objective is to measure and compare the partial pressure of oxygen in the artery to the inspired oxygen ratio (P/F ratio) on day 3 of mechanical ventilation. We will also collect and compare common variables used to evaluate lung injury and severity of respiratory failure in both groups. These variables and markers include: the Oxygenation index (OI) and standard blood gas parameters (PH, PaCO2 and PaO2).

Secondary Outcome Measures

Name	Time	Method
Amount/Duration of Sedative & Vasoactive Medication	Up to ICU discharge	Our second objective is to compare the amount and duration of sedative medication and vasoactive medication per patient per/day required in each group. Duration of vasoactive medications and sedation (# of days) and quantitative amounts per kilogram will be compared. Measurements will include Mean Arterial Blood Pressure (MAP), Central venous pressure (CVP), and daily fluid balance between patients on AC and APRV.
Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.	Up to ICU discharge	Our third objective is to evaluate the feasibility of 2 previously developed APRV paper protocols (APRVa and APRVb) and document the clinician compliance with each paper APRV protocol. We will also track common events associated with mechanical ventilation. The incidence of pneumothorax defined as any ventilator-barotrauma resulting in chest tube placement, will be carefully followed.

Trial Locations

Locations (2)

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States