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ARDSnet Protocol vs. Open Lung Approach in ARDS

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ClinicalTrials.gov Identifier: NCT00431158
Recruitment Status : Completed
First Posted : February 5, 2007
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Robert M. Kacmarek, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE February 1, 2007
First Posted Date  ICMJE February 5, 2007
Last Update Posted Date September 18, 2014
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2008)
60 day mortality [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
60 day mortality
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2008)
  • ICU mortality [ Time Frame: Duration of ICU stay ]
  • Hospital mortality [ Time Frame: Duration of hospital stay ]
  • 28 day mortality [ Time Frame: 28 days ]
  • 180 day mortality [ Time Frame: 180 days ]
  • 365 day mortality [ Time Frame: 365 days ]
  • Ventilator free days [ Time Frame: Hospital stay ]
  • Length of ICU stay [ Time Frame: Duration of ICU stay ]
  • Development of extra-pulmonary organ failures [ Time Frame: Duration of hospital stay ]
  • Duration of hospitalization [ Time Frame: Duration of hospital stay ]
  • Incidence of barotrauma [ Time Frame: Duration of hospital stay ]
  • Systemic inflammatory mediator levels [ Time Frame: Duration of hospital stay ]
  • Lung function 6 months after discharge [ Time Frame: 6 months ]
  • Lung function 12 months after discharge [ Time Frame: 12 months ]
  • Need for rescue therapy [ Time Frame: Duration of hospital stay ]
  • Ventilation associated pneumonia rate [ Time Frame: Duration of hospital stay ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
  • ICU mortality
  • Hospital mortality
  • 28 day mortality
  • 180 day mortality
  • 365 day mortality
  • Ventilator free days
  • Length of ICU stay
  • Development of extra-pulmonary organ failures
  • Duration of hospitalization
  • Incidence of barotrauma
  • Systemic inflammatory mediator levels
  • Lung function 6 months after discharge
  • Lung function 12 months after discharge
  • Need for rescue therapy
  • Ventilation associated pneumonia rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ARDSnet Protocol vs. Open Lung Approach in ARDS
Official Title  ICMJE ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Distress Syndrome, Adult
Intervention  ICMJE Other: Different Mechanical Ventilation Protocols

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

Study Arms  ICMJE
  • Active Comparator: 1
    ARDSnet Protocol
    Intervention: Other: Different Mechanical Ventilation Protocols
  • Active Comparator: 2
    OLA Protocol
    Intervention: Other: Different Mechanical Ventilation Protocols
Publications * Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martínez D, Hernández M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suárez-Sipmann F; Open Lung Approach Network. Open Lung Approach for the Acute Respiratory Distress Syndrome: A Pilot, Randomized Controlled Trial. Crit Care Med. 2016 Jan;44(1):32-42. doi: 10.1097/CCM.0000000000001383.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2012)
224
Original Enrollment  ICMJE
 (submitted: February 1, 2007)
600
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00431158
Other Study ID Numbers  ICMJE 2006-P-001878
BWH IRB Assurance #FWA00000484
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert M. Kacmarek, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert M Kacmarek, Ph.D., R.R.T Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP