ARDSnet Protocol vs. Open Lung Approach in ARDS

Completed · Not applicable

Conditions studied: Respiratory Distress Syndrome, Adult

In brief

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.

Key facts

Study ID

NCT00431158

Run by

Massachusetts General Hospital

People needed

224

Starts

2007-01-01

Expected to finish

2013-03-01

Last updated by the study team

2014-09-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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