Status:
COMPLETED
ARDSnet Protocol vs. Open Lung Approach in ARDS
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18-80 years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00431158
Start Date
January 1 2007
End Date
March 1 2013
Last Update
September 18 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114