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

Primary Purpose

Respiratory Failure, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mechanical Ventilation
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring ALI, ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Intermountain Medical CenterRecruiting
  • LDS HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

APRV ls

AC/VC Conventional Ventilation

APRV h

Arm Description

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

Standard volume control ventilation with the ARDS Net protocol.

APRV Habashi protocol which sets Plow equal to 0.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 19, 2010
Last Updated
August 24, 2015
Sponsor
Intermountain Health Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01339533
Brief Title
Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation
Official Title
Airway Pressure Release Ventilation (APRV) vs. Conventional Volume Control Mechanical Ventilation for Patients With Respiratory Failure Requiring Invasive Mechanical Ventilator Support
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermountain Health Care, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)
Keywords
ALI, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
APRV ls
Arm Type
Experimental
Arm Description
APRV low stretch will titrate Plow to maintain release volumes between 4 and 8 cc/kg.
Arm Title
AC/VC Conventional Ventilation
Arm Type
Active Comparator
Arm Description
Standard volume control ventilation with the ARDS Net protocol.
Arm Title
APRV h
Arm Type
Experimental
Arm Description
APRV Habashi protocol which sets Plow equal to 0.
Intervention Type
Device
Intervention Name(s)
Mechanical Ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
P/F Ratio on Day 3 of Mechanical Ventilation
Description
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).
Time Frame
Day 3
Secondary Outcome Measure Information:
Title
Amount/Duration of Sedative & Vasoactive Medication
Description
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.
Time Frame
Up to ICU discharge
Title
Evaluate Feasibility & Clinical Compliance with 2 APRV Paper Protocols.
Description
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.
Time Frame
Up to ICU discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliotte Hirshberg, MD
Phone
801-232-9120
Email
ellie.hirshberg@imail.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliotte Hirshberg, MD
Organizational Affiliation
IHC Health Services, Inc., Dba: Intermountain Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eliotte Hirshberg, MD
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Terry Clemmer, MD

12. IPD Sharing Statement

Learn more about this trial

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

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