Ventilation strategy using low tidal volumes, recruitment maneuvers, and high positive end-expiratory pressure for acute lung injury and acute respiratory distress syndrome: a randomized controlled trial.

Abstract

CONTEXT:

Low-tidal-volume ventilation reduces mortality in critically ill patients with acute lung injury and acute respiratory distress syndrome. Instituting additional strategies to open collapsed lung tissue may further reduce mortality.

OBJECTIVE:

To compare an established low-tidal-volume ventilation strategy with an experimental strategy based on the original "open-lung approach," combining low tidal volume, lung recruitment maneuvers, and high positive-end-expiratory pressure.

DESIGN AND SETTING:

Randomized controlled trial with concealed allocation and blinded data analysis conducted between August 2000 and March 2006 in 30 intensive care units in Canada, Australia, and Saudi Arabia.

PATIENTS:

Nine hundred eighty-three consecutive patients with acute lung injury and a ratio of arterial oxygen tension to inspired oxygen fraction not exceeding 250.

INTERVENTIONS:

The control strategy included target tidal volumes of 6 mL/kg of predicted body weight, plateau airway pressures not exceeding 30 cm H2O, and conventional levels of positive end-expiratory pressure (n = 508). The experimental strategy included target tidal volumes of 6 mL/kg of predicted body weight, plateau pressures not exceeding 40 cm H2O, recruitment maneuvers, and higher positive end-expiratory pressures (n = 475).

MAIN OUTCOME MEASURE:

All-cause hospital mortality.

RESULTS:

Eighty-five percent of the 983 study patients met criteria for acute respiratory distress syndrome at enrollment. Tidal volumes remained similar in the 2 groups, and mean positive end-expiratory pressures were 14.6 (SD, 3.4) cm H2O in the experimental group vs 9.8 (SD, 2.7) cm H2O among controls during the first 72 hours (P < .001). All-cause hospital mortality rates were 36.4% and 40.4%, respectively (relative risk [RR], 0.90; 95% confidence interval [CI], 0.77-1.05; P = .19). Barotrauma rates were 11.2% and 9.1% (RR, 1.21; 95% CI, 0.83-1.75; P = .33). The experimental group had lower rates of refractory hypoxemia (4.6% vs 10.2%; RR, 0.54; 95% CI, 0.34-0.86; P = .01), death with refractory hypoxemia (4.2% vs 8.9%; RR, 0.56; 95% CI, 0.34-0.93; P = .03), and previously defined eligible use of rescue therapies (5.1% vs 9.3%; RR, 0.61; 95% CI, 0.38-0.99; P = .045).

CONCLUSIONS:

For patients with acute lung injury and acute respiratory distress syndrome, a multifaceted protocolized ventilation strategy designed to recruit and open the lung resulted in no significant difference in all-cause hospital mortality or barotrauma compared with an established low-tidal-volume protocolized ventilation strategy. This "open-lung" strategy did appear to improve secondary end points related to hypoxemia and use of rescue therapies.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00182195.

• Authors: Maureen O Meade, Deborah J Cook, Gordon H Guyatt, Arthur S Slutsky, Yaseen M Arabi, D James Cooper, Andrew R Davies, Lori E Hand, Qi Zhou, Lehana Thabane, Peggy Austin, Stephen Lapinsky, Alan Baxter, James Russell, Yoanna Skrobik, Juan J Ronco, Thomas E Stewart, Lung Open Ventilation Study Investigators
• Journal: JAMA (JAMA) Vol. 299 Issue 6 Pg. 637-45 (Feb 13 2008) ISSN: 1538-3598 [Electronic] United States
• PMID: 18270352 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Topics

• Adult
• Aged
• Female
• Hospital Mortality
• Humans
• Male
• Middle Aged
• Positive-Pressure Respiration
• Respiratory Distress Syndrome (physiopathology, therapy)
• Severity of Illness Index
• Survival Analysis
• Tidal Volume