ARDSnet Protocol vs. Open Lung Approach in ARDS

Mass General Brigham

Status

Completed

Conditions

Respiratory Distress Syndrome, Adult

Treatments

Other: Different Mechanical Ventilation Protocols

Study type

Interventional

Funder types

Other

Identifiers

NCT00431158

2006-P-001878

BWH IRB Assurance #FWA00000484

Details and patient eligibility

About

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.

Full 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.

Enrollment

224 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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