- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00431158
ARDSnet Protocol vs. Open Lung Approach in ARDS
ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
ARDSnet Protocol
|
OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol |
Active Comparator: 2
OLA Protocol
|
OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
60 day mortality
Time Frame: 60 days
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28 day mortality
Time Frame: 28 days
|
28 days
|
ICU mortality
Time Frame: Duration of ICU stay
|
Duration of ICU stay
|
Hospital mortality
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
180 day mortality
Time Frame: 180 days
|
180 days
|
365 day mortality
Time Frame: 365 days
|
365 days
|
Ventilator free days
Time Frame: Hospital stay
|
Hospital stay
|
Length of ICU stay
Time Frame: Duration of ICU stay
|
Duration of ICU stay
|
Development of extra-pulmonary organ failures
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Duration of hospitalization
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Incidence of barotrauma
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Systemic inflammatory mediator levels
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Lung function 6 months after discharge
Time Frame: 6 months
|
6 months
|
Lung function 12 months after discharge
Time Frame: 12 months
|
12 months
|
Need for rescue therapy
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Ventilation associated pneumonia rate
Time Frame: Duration of hospital stay
|
Duration of hospital stay
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert M Kacmarek, Ph.D., R.R.T, Massachusetts General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006-P-001878
- BWH IRB Assurance #FWA00000484
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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