ARDSnet Protocol vs. Open Lung Approach in ARDS

NCT ID: NCT00431158

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2013-03-31

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.

Conditions

Respiratory Distress Syndrome, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

ARDSnet Protocol

Group Type: ACTIVE_COMPARATOR

Different Mechanical Ventilation Protocols

Intervention Type: OTHER

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

2

OLA Protocol

Group Type: ACTIVE_COMPARATOR

Different Mechanical Ventilation Protocols

Intervention Type: OTHER

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

Interventions

Different Mechanical Ventilation Protocols

OLA Group: Open lung approach protocol and recruitment maneuvers

ARDSnet Group: ARDSnet protocol

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Robert M. Kacmarek

Professor of Anesthesia, Director of Respiratory Care Services

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26672923 (View on PubMed)

Other Identifiers

BWH IRB Assurance #FWA00000484

Identifier Type: -

Identifier Source: secondary_id

2006-P-001878

Identifier Type: -

Identifier Source: org_study_id