ARDSnet Protocol vs. Open Lung Approach in ARDS

NCT00431158 | Completed DMC

• 2 other identifiers: 2006-P-001878BWH IRB Assurance #FWA00000484
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome, Adult

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 60 day mortality

  60 days

Secondary Outcomes (15)

• ICU mortality

  Duration of ICU stay

• Hospital mortality

  Duration of hospital stay

• 28 day mortality

  28 days

• 180 day mortality

  180 days

• 365 day mortality

  365 days

Study Arms (2)

1

ACTIVE COMPARATOR

ARDSnet Protocol

Other: Different Mechanical Ventilation Protocols

2

ACTIVE COMPARATOR

OLA Protocol

Other: Different Mechanical Ventilation Protocols

Interventions

Different Mechanical Ventilation Protocols OTHER

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

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 26672923 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Robert M Kacmarek, Ph.D., R.R.T

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesia, Director of Respiratory Care Services

Study Record Dates

• First Submitted: February 1, 2007
• First Posted: February 5, 2007
• Study Start: January 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (1)