Lower tidal volume strategy (≈3 ml/kg) combined with extracorporeal CO2 removal versus ‘conventional’ protective ventilation (6 ml/kg) in severe ARDS

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Abstract

Background

Acute respiratory distress syndrome is characterized by damage to the lung caused by various insults, including ventilation itself, and tidal hyperinflation can lead to ventilator induced lung injury (VILI). We investigated the effects of a low tidal volume ( V _T) strategy ( V _T ≈ 3 ml/kg/predicted body weight [PBW]) using pumpless extracorporeal lung assist in established ARDS.

Methods

Seventy-nine patients were enrolled after a ‘stabilization period’ (24 h with optimized therapy and high PEEP). They were randomly assigned to receive a low V _T ventilation (≈3 ml/kg) combined with extracorporeal CO ₂ elimination, or to a ARDSNet strategy (≈6 ml/kg) without the extracorporeal device. The primary outcome was the 28-days and 60-days ventilator-free days (VFD). Secondary outcome parameters were respiratory mechanics, gas exchange, analgesic/sedation use, complications and hospital mortality.

Results

Ventilation with very low V _T’s was easy to implement with extracorporeal CO ₂-removal. VFD’s within 60 days were not different between the study group (33.2 ± 20) and the control group (29.2 ± 21, p = 0.469), but in more hypoxemic patients (PaO ₂/FIO ₂ ≤150) a post hoc analysis demonstrated significant improved VFD-60 in study patients (40.9 ± 12.8) compared to control (28.2 ± 16.4, p = 0.033). The mortality rate was low (16.5 %) and did not differ between groups.

Conclusions

The use of very low V _T combined with extracorporeal CO ₂ removal has the potential to further reduce VILI compared with a ‘normal’ lung protective management. Whether this strategy will improve survival in ARDS patients remains to be determined (Clinical trials NCT 00538928).

Electronic supplementary material

The online version of this article (doi:10.1007/s00134-012-2787-6) contains supplementary material, which is available to authorized users.

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Most cited references 25

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Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome.

Pier Paolo Terragni, Giulio Rosboch, Andrea Tealdi … (2007)

Tidal volume and plateau pressure limitation decreases mortality in acute respiratory distress syndrome. Computed tomography demonstrated a small, normally aerated compartment on the top of poorly aerated and nonaerated compartments that may be hyperinflated by tidal inflation. We hypothesized that despite tidal volume and plateau pressure limitation, patients with a larger nonaerated compartment are exposed to tidal hyperinflation of the normally aerated compartment. Pulmonary computed tomography at end-expiration and end-inspiration was obtained in 30 patients ventilated with a low tidal volume (6 ml/kg predicted body weight). Cluster analysis identified 20 patients in whom tidal inflation occurred largely in the normally aerated compartment (69.9 +/- 6.9%; "more protected"), and 10 patients in whom tidal inflation occurred largely within the hyperinflated compartments (63.0 +/- 12.7%; "less protected"). The nonaerated compartment was smaller and the normally aerated compartment was larger in the more protected patients than in the less protected patients (p = 0.01). Pulmonary cytokines were lower in the more protected patients than in the less protected patients (p < 0.05). Ventilator-free days were 7 +/- 8 and 1 +/- 2 d in the more protected and less protected patients, respectively (p = 0.01). Plateau pressure ranged between 25 and 26 cm H(2)O in the more protected patients and between 28 and 30 cm H(2)O in the less protected patients (p = 0.006). Limiting tidal volume to 6 ml/kg predicted body weight and plateau pressure to 30 cm H(2)O may not be sufficient in patients characterized by a larger nonaerated compartment.

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Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal.

Pier Paolo Terragni, Lorenzo Del Sorbo, Luciana Mascia … (2009)

Tidal hyperinflation may occur in patients with acute respiratory distress syndrome who are ventilated with a tidal volume (VT) of 6 ml/kg of predicted body weight develop a plateau pressure (PPLAT) of 28 < or = PPLAT < or = 30 cm H2O. The authors verified whether VT lower than 6 ml/kg may enhance lung protection and that consequent respiratory acidosis may be managed by extracorporeal carbon dioxide removal. PPLAT, lung morphology computed tomography, and pulmonary inflammatory cytokines (bronchoalveolar lavage) were assessed in 32 patients ventilated with a VT of 6 ml/kg. Data are provided as mean +/- SD or median and interquartile (25th and 75th percentile) range. In patients with 28 < or = PPLAT < or = 30 cm H2O (n = 10), VT was reduced from 6.3 +/- 0.2 to 4.2 +/- 0.3 ml/kg, and PPLAT decreased from 29.1 +/- 1.2 to 25.0 +/- 1.2 cm H2O (P < 0.001); consequent respiratory acidosis (Paco2 from 48.4 +/- 8.7 to 73.6 +/- 11.1 mmHg and pH from 7.36 +/- 0.03 to 7.20 +/- 0.02; P < 0.001) was managed by extracorporeal carbon dioxide removal. Lung function, morphology, and pulmonary inflammatory cytokines were also assessed after 72 h. Extracorporeal assist normalized Paco2 (50.4 +/- 8.2 mmHg) and pH (7.32 +/- 0.03) and allowed use of VT lower than 6 ml/kg for 144 (84-168) h. The improvement of morphological markers of lung protection and the reduction of pulmonary cytokines concentration (P < 0.01) were observed after 72 h of ventilation with VT lower than 6 ml/kg. No patient-related complications were observed. VT lower than 6 ml/Kg enhanced lung protection. Respiratory acidosis consequent to low VT ventilation was safely and efficiently managed by extracorporeal carbon dioxide removal.

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Statistical evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome.

Joshua Schoenfeld, William Bernard, (2002)

Trials of potential new therapies in acute lung injury are difficult and expensive to conduct. This article is designed to determine the utility, behavior, and statistical properties of a new primary end point for such trials, ventilator-free days, defined as days alive and free from mechanical ventilation. Describing the nuances of this outcome measure is particularly important because using it, while ignoring mortality, could result in misleading conclusions. To develop a model for the duration of ventilation and mortality and fit the model by using data from a recently completed clinical trial. To determine the appropriate test statistic for the new measure and derive a formula for power. To determine a formula for the probability that the test statistic will reject the null hypothesis and mortality will simultaneously show improvement. To plot power curves for the test statistic and determine sample sizes for reasonable alternative hypotheses. Intensive care units. Patients with acute respiratory distress syndrome or acute lung injury as defined by the American-European Consensus Conference. The proposed model fit the clinical data. Ventilator-free days were improved by lower tidal volume ventilation, but the improvement was mostly caused by the improved mortality rate, so trials that expected similar effects would only have modest increase in power if they used ventilator-free days as their primary end point rather than 28-day mortality. Similar results were obtained using the model in two groups segregated by low or high Acute Physiology and Chronic Health Evaluation score. On the other hand, if patients are divided into two groups on the basis of the lung injury score, both the duration of ventilation and mortality are lower in the low lung injury score group. A trial of a treatment that had a similar clinical effect would have a large increase in power, allowing for a reduction in the required sample size. Use of ventilator-free days as a trial end point allows smaller sample sizes if it is assumed that the treatment being tested simultaneously reduces the duration of ventilation and improves mortality. It is unlikely that a treatment that led to higher mortality could lead to a statistically significant improvement in ventilator-free days. This would be especially true if the treatment were also required to produce a nominal improvement in mortality.

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Author and article information

Contributors

: thomas.bein@klinik.uni-regensburg.de

Journal

Journal ID (nlm-ta): Intensive Care Med

Journal ID (iso-abbrev): Intensive Care Med

Title: Intensive Care Medicine

Publisher: Springer-Verlag (Berlin/Heidelberg )

ISSN (Print): 0342-4642

ISSN (Electronic): 1432-1238

Publication date (Electronic): 10 January 2013

Publication date PMC-release: 10 January 2013

Publication date (Print): May 2013

Volume: 39

Issue: 5

Pages: 847-856

Affiliations

[ ]Department of Anesthesia and Operative Intensive Care, Regensburg University Hospital, Regensburg, Germany

[ ]Department of Anesthesia and Operative Intensive Care Medicine, Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum and Campus Charité Mitte, Berlin, Germany

[ ]Department of Internal Medicine II, Regensburg University Hospital, Regensburg, Germany

[ ]Intensive Care Unit, Department of Internal Medicine I, Vienna General Hospital, Medical University of Vienna, Vienna, Austria

[ ]Department of Intensive Care Medicine, HELIOS Klinikum Berlin-Buch, Berlin, Germany

[ ]Department of Anaesthesia and Critical Care, University of Würzburg, Würzburg, Germany

[ ]Department of Intensive Care, University Hospital Aachen, RWTH Aachen University, Aachen, Germany

[ ]Intensive Care Unit, Division of Gastroenterology, Department of Internal Medicine III, Vienna General Hospital, Medical University of Vienna, Vienna, Austria

[ ]Department of Cardiothoracic Surgery, Regensburg University Hospital, Regensburg, Germany

[ ]Interdepartmental Division of Critical Care Medicine, Department of Medicine, Keenan Research Center at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital, University of Toronto, Toronto, Canada

[ ]SOSTANA GmbH, Biometric Statistical Analyses, Berlin, Germany

[ ]Department of Anesthesia and Critical Care, Regensburg University Hospital, 93042 Regensburg, Germany

Article

Publisher ID: 2787

DOI: 10.1007/s00134-012-2787-6

PMC ID: 3625408

PubMed ID: 23306584

SO-VID: 16a1d15d-85ab-4c6c-be98-3e85427ec99f

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

History

Date received : 12 July 2012

Date accepted : 29 November 2012

Custom metadata

ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: lung protective ventilation,pumpless extracorporeal lung support,carbon dioxide removal,acute respiratory distress syndrome,ultraprotective ventilation

Data availability:

ScienceOpen disciplines: Emergency medicine & Trauma

Keywords: lung protective ventilation, pumpless extracorporeal lung support, carbon dioxide removal, acute respiratory distress syndrome, ultraprotective ventilation