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ARDSnet Protocol vs. Open Lung Approach in ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00431158
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Other: Different Mechanical Ventilation Protocols Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
Study Start Date : January 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Active Comparator: 1
ARDSnet Protocol
Other: Different Mechanical Ventilation Protocols

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

Active Comparator: 2
OLA Protocol
Other: Different Mechanical Ventilation Protocols

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

Primary Outcome Measures :
  1. 60 day mortality [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: Duration of ICU stay ]
  2. Hospital mortality [ Time Frame: Duration of hospital stay ]
  3. 28 day mortality [ Time Frame: 28 days ]
  4. 180 day mortality [ Time Frame: 180 days ]
  5. 365 day mortality [ Time Frame: 365 days ]
  6. Ventilator free days [ Time Frame: Hospital stay ]
  7. Length of ICU stay [ Time Frame: Duration of ICU stay ]
  8. Development of extra-pulmonary organ failures [ Time Frame: Duration of hospital stay ]
  9. Duration of hospitalization [ Time Frame: Duration of hospital stay ]
  10. Incidence of barotrauma [ Time Frame: Duration of hospital stay ]
  11. Systemic inflammatory mediator levels [ Time Frame: Duration of hospital stay ]
  12. Lung function 6 months after discharge [ Time Frame: 6 months ]
  13. Lung function 12 months after discharge [ Time Frame: 12 months ]
  14. Need for rescue therapy [ Time Frame: Duration of hospital stay ]
  15. Ventilation associated pneumonia rate [ Time Frame: Duration of hospital stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00431158

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Robert M Kacmarek, Ph.D., R.R.T Massachusetts General Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Robert M. Kacmarek, Professor of Anesthesia, Director of Respiratory Care Services, Massachusetts General Hospital Identifier: NCT00431158    
Other Study ID Numbers: 2006-P-001878
BWH IRB Assurance #FWA00000484
First Posted: February 5, 2007    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Robert M. Kacmarek, Massachusetts General Hospital:
Acute Respiratory Distress Syndrome
Respiratory failure
Mechanical Ventilation
Positive end expiratory pressure
Lung recruitment maneuver
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury