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ARDSnet Protocol vs. Open Lung Approach in ARDS

Primary Purpose

Respiratory Distress Syndrome, Adult

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Different Mechanical Ventilation Protocols

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Acute Respiratory Distress Syndrome, ARDS, Respiratory failure, Mechanical Ventilation, Positive end expiratory pressure, Lung recruitment maneuver

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

ARDSnet Protocol

OLA Protocol

Outcomes

Primary Outcome Measures

60 day mortality

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00431158

First Posted

February 1, 2007

Last Updated

September 17, 2014

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00431158

Brief Title

ARDSnet Protocol vs. Open Lung Approach in ARDS

Official Title

ARDSnet Protocol vs. the Open Lung Approach for the Ventilatory Management of Severe, Established ARDS: A Global Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

January 2007 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome, Adult

Keywords

Acute Respiratory Distress Syndrome, ARDS, Respiratory failure, Mechanical Ventilation, Positive end expiratory pressure, Lung recruitment maneuver

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

ARDSnet Protocol

Arm Title

Arm Type

Active Comparator

Arm Description

OLA Protocol

Intervention Type

Other

Intervention Name(s)

Different Mechanical Ventilation Protocols

Intervention Description

OLA Group: Open lung approach protocol and recruitment maneuvers ARDSnet Group: ARDSnet protocol

Primary Outcome Measure Information:

Title

60 day mortality

Time Frame

60 days

Secondary Outcome Measure Information:

Title

ICU mortality

Time Frame

Duration of ICU stay

Title

Hospital mortality

Time Frame

Duration of hospital stay

Title

28 day mortality

Time Frame

28 days

Title

180 day mortality

Time Frame

180 days

Title

365 day mortality

Time Frame

365 days

Title

Ventilator free days

Time Frame

Hospital stay

Title

Length of ICU stay

Time Frame

Duration of ICU stay

Title

Development of extra-pulmonary organ failures

Time Frame

Duration of hospital stay

Title

Duration of hospitalization

Time Frame

Duration of hospital stay

Title

Incidence of barotrauma

Time Frame

Duration of hospital stay

Title

Systemic inflammatory mediator levels

Time Frame

Duration of hospital stay

Title

Lung function 6 months after discharge

Time Frame

6 months

Title

Lung function 12 months after discharge

Time Frame

12 months

Title

Need for rescue therapy

Time Frame

Duration of hospital stay

Title

Ventilation associated pneumonia rate

Time Frame

Duration of hospital stay

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert M Kacmarek, Ph.D., R.R.T

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26672923

Citation

Kacmarek RM, Villar J, Sulemanji D, Montiel R, Ferrando C, Blanco J, Koh Y, Soler JA, Martinez D, Hernandez M, Tucci M, Borges JB, Lubillo S, Santos A, Araujo JB, Amato MB, Suarez-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.

Results Reference

derived

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ARDSnet Protocol vs. Open Lung Approach in ARDS

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