ARDSnet Protocol vs. Open Lung Approach in ARDS - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00431158

Purpose

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.

Condition	Intervention
Respiratory Distress Syndrome, Adult	Other: Different Mechanical Ventilation Protocols

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

60 day mortality [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ICU mortality [ Time Frame: Duration of ICU stay ] [ Designated as safety issue: No ]
Hospital mortality [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
180 day mortality [ Time Frame: 180 days ] [ Designated as safety issue: No ]
365 day mortality [ Time Frame: 365 days ] [ Designated as safety issue: No ]
Ventilator free days [ Time Frame: Hospital stay ] [ Designated as safety issue: No ]
Length of ICU stay [ Time Frame: Duration of ICU stay ] [ Designated as safety issue: No ]
Development of extra-pulmonary organ failures [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
Duration of hospitalization [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
Incidence of barotrauma [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
Systemic inflammatory mediator levels [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
Lung function 6 months after discharge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Lung function 12 months after discharge [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Need for rescue therapy [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]
Ventilation associated pneumonia rate [ Time Frame: Duration of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	January 2007
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator ARDSnet Protocol	Other: Different Mechanical Ventilation Protocols OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol
2: Active Comparator OLA Protocol	Other: Different Mechanical Ventilation Protocols OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431158

Contacts

Contact: Robert M Kacmarek, Ph.D., RRT	617-724-4480	rkacmarek@partners.org
Contact: Demet S Suleymanci, MD	617-724-4498	dsuleymanci@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: R. Scott Harris, MD

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Robert M Kacmarek, Ph.D., R.R.T

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Robert Kacmarek, PhD, RRT )
Study ID Numbers:	2006-P-001878, BWH IRB Assurance #FWA00000484
Study First Received:	February 1, 2007
Last Updated:	February 9, 2009
ClinicalTrials.gov Identifier:	NCT00431158 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Acute Respiratory Distress Syndrome
ARDS
Respiratory failure

Mechanical Ventilation
Positive end expiratory pressure
Lung recruitment maneuver

Study placed in the following topic categories:

Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute Respiratory Distress Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Respiratory Tract Diseases
Lung Diseases

Syndrome
Respiration Disorders
Respiratory Distress Syndrome, Adult

ClinicalTrials.gov processed this record on May 07, 2009