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Effects of a clinical trial on mechanical ventilation practices in patients with acute lung injury.
Am J Respir Crit Care Med. 2008 Jun 01; 177(11):1215-22.AJ

Abstract

RATIONALE

In a clinical trial by the Acute Respiratory Distress Syndrome Network (ARDSNet), mechanical ventilation with tidal volumes of 6 ml/kg decreased mortality from acute lung injury. However, interpretations of these results generated controversy and it was unclear if this trial would change usual-care practices.

OBJECTIVES

First, to determine if clinical practices at ARDSNet hospitals changed after the tidal volume trial. Second, to determine if tidal volume and plateau pressure (Pplat) within 48 hours before randomization affected hospital mortality in patients subsequently managed with 6 ml/kg predicted body weight (PBW).

METHODS

We used preenrollment data from 2,451 patients enrolled in six trials (1996-2005) to describe changes in tidal volume over time. We used logistic regression to determine if preenrollment tidal volume or Pplat affected mortality.

MEASUREMENTS AND MAIN RESULTS

Median preenrollment tidal volume decreased from 10.3 ml/kg PBW (range, 4.3-17.1) during the tidal volume trial (1996-1999) to 7.3 ml/kg PBW (range, 3.9-16.2) after its completion (P < 0.001). Preenrollment tidal volume was not associated with mortality (P = 0.566). The odds of death increased multiplicatively with each cm H(2)O of preenrollment Pplat (P < 0.001) (e.g., the odds of death was 1.37 times greater when preenrollment Pplat increased by 10 cm H(2)O).

CONCLUSIONS

Physicians used lower tidal volumes after publication of the tidal volume trial. Preenrollment Pplat was strongly associated with mortality, and may reflect disease severity independent of tidal volume. Pplat measured early in the course of acute lung injury, after accounting for tidal volume, is a respiratory system-specific value with strong prognostic significance.

Authors+Show Affiliations

Division of Pulmonary and Critical Care, School of Medicine, The Johns Hopkins University, Baltimore, MD 21205, USA. wcheckl1@jhmi.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

18356562

Citation

Checkley, William, et al. "Effects of a Clinical Trial On Mechanical Ventilation Practices in Patients With Acute Lung Injury." American Journal of Respiratory and Critical Care Medicine, vol. 177, no. 11, 2008, pp. 1215-22.
Checkley W, Brower R, Korpak A, et al. Effects of a clinical trial on mechanical ventilation practices in patients with acute lung injury. Am J Respir Crit Care Med. 2008;177(11):1215-22.
Checkley, W., Brower, R., Korpak, A., & Thompson, B. T. (2008). Effects of a clinical trial on mechanical ventilation practices in patients with acute lung injury. American Journal of Respiratory and Critical Care Medicine, 177(11), 1215-22. https://doi.org/10.1164/rccm.200709-1424OC
Checkley W, et al. Effects of a Clinical Trial On Mechanical Ventilation Practices in Patients With Acute Lung Injury. Am J Respir Crit Care Med. 2008 Jun 1;177(11):1215-22. PubMed PMID: 18356562.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of a clinical trial on mechanical ventilation practices in patients with acute lung injury. AU - Checkley,William, AU - Brower,Roy, AU - Korpak,Anna, AU - Thompson,B Taylor, AU - ,, Y1 - 2008/03/20/ PY - 2008/3/22/pubmed PY - 2008/6/5/medline PY - 2008/3/22/entrez SP - 1215 EP - 22 JF - American journal of respiratory and critical care medicine JO - Am J Respir Crit Care Med VL - 177 IS - 11 N2 - RATIONALE: In a clinical trial by the Acute Respiratory Distress Syndrome Network (ARDSNet), mechanical ventilation with tidal volumes of 6 ml/kg decreased mortality from acute lung injury. However, interpretations of these results generated controversy and it was unclear if this trial would change usual-care practices. OBJECTIVES: First, to determine if clinical practices at ARDSNet hospitals changed after the tidal volume trial. Second, to determine if tidal volume and plateau pressure (Pplat) within 48 hours before randomization affected hospital mortality in patients subsequently managed with 6 ml/kg predicted body weight (PBW). METHODS: We used preenrollment data from 2,451 patients enrolled in six trials (1996-2005) to describe changes in tidal volume over time. We used logistic regression to determine if preenrollment tidal volume or Pplat affected mortality. MEASUREMENTS AND MAIN RESULTS: Median preenrollment tidal volume decreased from 10.3 ml/kg PBW (range, 4.3-17.1) during the tidal volume trial (1996-1999) to 7.3 ml/kg PBW (range, 3.9-16.2) after its completion (P < 0.001). Preenrollment tidal volume was not associated with mortality (P = 0.566). The odds of death increased multiplicatively with each cm H(2)O of preenrollment Pplat (P < 0.001) (e.g., the odds of death was 1.37 times greater when preenrollment Pplat increased by 10 cm H(2)O). CONCLUSIONS: Physicians used lower tidal volumes after publication of the tidal volume trial. Preenrollment Pplat was strongly associated with mortality, and may reflect disease severity independent of tidal volume. Pplat measured early in the course of acute lung injury, after accounting for tidal volume, is a respiratory system-specific value with strong prognostic significance. SN - 1535-4970 UR - https://www.unboundmedicine.com/medline/citation/18356562/Effects_of_a_clinical_trial_on_mechanical_ventilation_practices_in_patients_with_acute_lung_injury_ DB - PRIME DP - Unbound Medicine ER -