ARDSnet Protocol vs. Open Lung Approach in ARDS

September 17, 2014 updated by: Robert M. Kacmarek, Massachusetts General Hospital

ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial

Many patients with Acute Respiratory Distress Syndrome or ARDS need breathing support that is provided by a machine called a ventilator or respirator. The purpose of this study is to find out if a new method of setting the ventilator for patients with severe ARDS is better than the standard, commonly used way of setting the ventilator.

Study Overview

Detailed Description

The ARDSnet protocol is the current, standard of care for ARDS. Mechanical ventilation is managed using low tidal volumes, relatively high respiratory rates, with oxygenation managed according to PEEP and FIO2 relationships as defined in a table. This study compares the ARDSnet protocol with an open lung approach to mechanical ventilation. The open lung approach uses a technique to recruit collapsed lung areas and then uses the lowest PEEP level that prevents recollapse of recruited lung units. The best PEEP level is determined by a decremental PEEP trial involving a series of pressure measurements taken after the recruitment maneuver. Both the ARDSnet protocol and the open lung approach require low tidal volumes and plateau pressures.

Evidence suggests that using a mechanical ventilation strategy of recruitment maneuvers (to open the collapsed lung) followed by high PEEP (to prevent collapse of the opened lung) with control of transpulmonary pressure through lower plateau pressures would maximize homogeneity within the lung and as such, minimize shearing forces in the lung parenchyma, thus improving ventilation and outcome in mechanically ventilated ARDS patients.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Intubated and mechanically ventilated
  • Diagnosis of ARDS using American-European consensus criteria
  • Enrollment in study < 48 hours since diagnosis of ARDS
  • For 12-36 hrs. (ideally 12-24 hrs) after diagnosis of ARDS, patient must be ventilated as follows: Volume A/C, Tidal volume of 4-8 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, PEEP/FIO2 adjustments using ARDSnet table, Ventilator rate to keep PaCO2 = 35-60 mmHg
  • During the 12-36 hour(ideally 12-24 hr) period, PaO2/FIO2 must remain < 200 mm Hg for an ABG obtained 30 minutes after placement on the following specific ventilator settings: Volume A/C, Tidal volume = 6 ml/kg PBW, Plateau pressure ≤ 30 cmH2O, Inspiratory time ≤ 1 second, PEEP ≥ 10 cmH2O, FIO2 ≥ 0.5, Ventilator rate to keep PaCO2 = 35-60 mmHg
  • No lung recruitment maneuvers or adjunct therapy.
  • Total time on mechanical ventilation < 96 hrs. at time of randomization.

Exclusion Criteria:

  • Age < 18 years or > 80 years
  • Weight < 35 kg PBW
  • Body mass index > 60
  • Intubated 2° to acute exacerbation of a chronic pulmonary disease
  • Acute brain injury (ICP > 18 mmHg)
  • Immunosuppression 2° to chemo- or radiation therapy
  • Severe cardiac disease(one of the following): New York Heart Association Class 3 or 4, acute coronary syndrome or persistent ventricular tachyarrhythmias
  • Positive laboratory pregnancy test
  • Sickle cell disease
  • Neuromuscular disease
  • High risk of mortality within 3 months from cause other than ARDS, e.g. cancer
  • More than 2 organ failures (not including pulmonary system)
  • Documented lung barotrauma, i.e. chest tube placement other than for fluid drainage
  • Persistent hemodynamic instability or intractable shock
  • Penetrating chest trauma
  • Enrollment in another interventional study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ARDSnet Protocol

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

Active Comparator: 2
OLA Protocol

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
60 day mortality
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
28 day mortality
Time Frame: 28 days
28 days
ICU mortality
Time Frame: Duration of ICU stay
Duration of ICU stay
Hospital mortality
Time Frame: Duration of hospital stay
Duration of hospital stay
180 day mortality
Time Frame: 180 days
180 days
365 day mortality
Time Frame: 365 days
365 days
Ventilator free days
Time Frame: Hospital stay
Hospital stay
Length of ICU stay
Time Frame: Duration of ICU stay
Duration of ICU stay
Development of extra-pulmonary organ failures
Time Frame: Duration of hospital stay
Duration of hospital stay
Duration of hospitalization
Time Frame: Duration of hospital stay
Duration of hospital stay
Incidence of barotrauma
Time Frame: Duration of hospital stay
Duration of hospital stay
Systemic inflammatory mediator levels
Time Frame: Duration of hospital stay
Duration of hospital stay
Lung function 6 months after discharge
Time Frame: 6 months
6 months
Lung function 12 months after discharge
Time Frame: 12 months
12 months
Need for rescue therapy
Time Frame: Duration of hospital stay
Duration of hospital stay
Ventilation associated pneumonia rate
Time Frame: Duration of hospital stay
Duration of hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert M Kacmarek, Ph.D., R.R.T, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 5, 2007

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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