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

Airway Pressure Release Ventilation (APRV) vs. Conventional Volume Control Mechanical Ventilation for Patients With Respiratory Failure Requiring Invasive Mechanical Ventilator Support

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Failure; Acute Respiratory Distress Syndrome (ARDS); Acute Lung Injury (ALI)
• Intervention / Treatment: Device: Mechanical Ventilation

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 Type: Interventional
• Enrollment (Anticipated): 246
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eliotte Hirshberg, MD; Phone Number: 801-232-9120; Email: ellie.hirshberg@imail.org

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Recruiting
      • Intermountain Medical Center
      • Principal Investigator: Eliotte Hirshberg, MD
    • Salt Lake City, Utah, United States, 84143
      • Recruiting
      • LDS Hospital
      • Sub-Investigator: Terry Clemmer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APRV ls; APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.	Device: Mechanical Ventilation; Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.
Active Comparator: AC/VC Conventional Ventilation; Standard volume control ventilation with the ARDS Net protocol.	Device: Mechanical Ventilation; Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.
Experimental: APRV h; APRV Habashi protocol which sets Plow equal to 0.	Device: Mechanical Ventilation; Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P/F Ratio on Day 3 of Mechanical Ventilation	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).	Day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount/Duration of Sedative & Vasoactive Medication	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.	Up to ICU discharge
Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.	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.	Up to ICU discharge

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Eliotte Hirshberg, MD, IHC Health Services, Inc., Dba: Intermountain Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 19, 2011
• First Posted (Estimate): April 20, 2011

Study Record Updates

• Last Update Posted (Estimate): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: ARDS; ALI
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: APRV1015758