Mechanical ventilation guided by esophageal pressure in acute lung injury.
Open accessAbstract
BACKGROUND: Survival of patients with acute lung injury or the acute respiratory distress syndrome (ARDS) has been improved by ventilation with small tidal volumes and the use of positive end-expiratory pressure (PEEP); however, the optimal level of PEEP has been difficult to determine. In this pilot study, we estimated transpulmonary pressure with the use of esophageal balloon catheters. We reasoned that the use of pleural-pressure measurements, despite the technical limitations to the accuracy of such measurements, would enable us to find a PEEP value that could maintain oxygenation while preventing lung injury due to repeated alveolar collapse or overdistention. METHODS: We randomly assigned patients with acute lung injury or ARDS to undergo mechanical ventilation with PEEP adjusted according to measurements of esophageal pressure (the esophageal-pressure-guided group) or according to the Acute Respiratory Distress Syndrome Network standard-of-care recommendations (the control group). The primary end point was improvement in oxygenation. The secondary end points included respiratory-system compliance and patient outcomes. RESULTS: The study reached its stopping criterion and was terminated after 61 patients had been enrolled. The ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen at 72 hours was 88 mm Hg higher in the esophageal-pressure-guided group than in the control group (95% confidence interval, 78.1 to 98.3; P=0.002). This effect was persistent over the entire follow-up time (at 24, 48, and 72 hours; P=0.001 by repeated-measures analysis of variance). Respiratory-system compliance was also significantly better at 24, 48, and 72 hours in the esophageal-pressure-guided group (P=0.01 by repeated-measures analysis of variance). CONCLUSIONS: As compared with the current standard of care, a ventilator strategy using esophageal pressures to estimate the transpulmonary pressure significantly improves oxygenation and compliance. Multicenter clinical trials are needed to determine whether this approach should be widely adopted. (ClinicalTrials.gov number, NCT00127491.)
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There was considerable uncertainty about the variability of this outcome measure, and so the authors calculated a conservative sample size but included an interim analysis after recruiting 60 patients, in case their a priori estimates were too large and they had enough information at that stage to inform subsequent trials.
“There was considerable uncertainty about the variability of this outcome measure, and so the authors calculated a conservative sample size but included an interim analysis after recruiting 60 patients, in case their a priori estimates were too large and they had enough information at that stage to inform subsequent trials.”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials. (2016) · cites this paper as [20]
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Experimental — accuracy not yet measuredThe example is a pilot trial testing a surrogate outcome.
“The example is a pilot trial testing a surrogate outcome.”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials. (2016) · cites this paper as [20]
While the pilot study suggested benefit, the subsequent 200 patient multicentre RCT that compared PEEP titration guided by esophageal (PES) measurement versus empirical high PEEP-FiO2 titration, showed no significant difference in a composite outcome of death and days free from mechanical ventilation through day 28.
“While the pilot study suggested benefit [448], the subsequent 200 patient multicentre RCT that compared PEEP titration guided by esophageal (PES) measurement versus empirical high PEEP-FiO2 titration, showed no significant difference in a composite outcome of death and days free from mechanical ventilation through day 28 [449].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [448]
Esophageal pressure guided PEEP titration has been evaluated in two trials.
“Esophageal pressure guided PEEP titration has been evaluated in two trials [447, 448].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [448]
Pilot trials do sometimes assess potential effectiveness using surrogate outcomes.
“Nevertheless, pilot trials do sometimes assess potential effectiveness using surrogate outcomes. For example, oxygenation of the blood as a surrogate measure for improved lung function and survival [20] or the number of steps walked each day as a surrogate for clinical measures of heart disease [21].”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials (2016) · cites this paper as [20]
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- Authors
- Talmor, D., Sarge, T., Malhotra, A., O'Donnell, C. R., Ritz, R., Lisbon, A., Novack, V., & Loring, S. H.
- Affiliations
- Beth Israel Deaconess Medical Center (US)
- Brigham and Women's Hospital (US)
- Harvard University (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2008-11-13
- Volume
- 359
- Issue
- 20
- Pages
- 2095-2104
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC3969885
- OpenAlex
- W2116685432
- Semantic Scholar
- abb1f15bd7b13d8e4d23ceff473aae619f38e918
- Cited by
- 1,149
- References
- 41
- Citations by year
- 2026: 59 · 2025: 47 · 2024: 65 · 2023: 52 · 2022: 71 · 2021: 82 · 2020: 68 · 2019: 75 · 2018: 82 · 2017: 84 · 2016: 73 · 2015: 78 · 2014: 64 · 2013: 60 · 2012: 68
- FWCI
- 37.03
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Cardinal Health
- National Institutes of Health (7k24hl093218-06)
- National Heart, Lung, and Blood Institute (K24 HL-093218, HL52586, R01HL052586)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Respiratory Support and Mechanisms
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Neonatal Respiratory Health Research
- Health Sciences › Medicine › Critical Care and Intensive Care Medicine › Nosocomial Infections in ICU
- Keywords
- acute lung injury, acute respiratory distress syndrome, esophageal pressure, transpulmonary pressure, positive end-expiratory pressure, PEEP optimization, mechanical ventilation, oxygenation, respiratory compliance, esophageal balloon catheter, alveolar collapse
- MeSH terms
- Esophagus, Female, Humans, Intensive Care Units, Length of Stay, Lung, Male, Middle Aged, Oxygen, Pilot Projects, Positive-Pressure Respiration, Pressure, Respiratory Distress Syndrome, Tidal Volume, Multivariate Analysis, Acute Lung Injury
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