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Methylprednisolone to Prevent Post-Extubation Laryngeal Edema
Abstract & Commentary
By David J. Pierson, MD, Editor, Professor, Pulmonary and Critical Care Medicine, Harborview Medical Center, University of Washington, Seattle, is Editor for Critical Care Alert.
Synopsis: In a mixed population of adult ICU patients who had been intubated for at least 36 hours, administration of 80 mg of methylprednisolone over the 12 hours preceding extubation substantially reduced the incidence of post-extubation laryngeal edema and the need for re-intubation.
Source: Francois B, et al. Lancet. 2007;369:1083-1089.
In this multicenter clinical trial from France, Francois and associates sought to determine whether methylprednisolone administered prior to extubation would prevent post-extubation laryngeal edema (PELE) and the need for re-intubation. They studied adult patients intubated for at least 36 hours for acute respiratory failure, in whom extubation was planned the following day. In a randomized, double-blind design, they gave such patients either methylprednisolone, 20 mg, or saline intravenously at 12, 8, and 4 hours prior to extubation, and also at the time the endotracheal tube was removed—for a total of 80 mg in the active treatment group. The investigators prospectively evaluated all patients for laryngeal edema (clinically defined as the acute development of upper respiratory obstruction) on 8 examinations over the 24 hours following extubation, and examined the cords visually at the time of reintubation when this was required.
The 2 patient groups were well matched, with 64% male and median age 66 years. Patients had similar frequencies of medical illness (62%), surgical conditions (19%), and trauma (19%). The median duration of intubation prior to randomization was 6 days. Of 761 patients entered into the study, data from 698 were included in the analysis. PELE developed in 76 of the 343 placebo-treated patients (22%) as compared to 11 of the 355 patients who received methylprednisolone (3%; p < 0.001). Re-intubation because of PELE occurred in 14 of 26 (54%) vs 1 of 13 (8%) of the patients on placebo vs methylprednisolone, respectively (P = 0.005); overall rates of re-intubation were 26/343 (8%) vs 13/355 (4%), respectively (p = 0.02). By univariate analysis of the data, patients who developed PELE were more likely to be female, of shorter height, admitted for trauma, and intubated orally with larger endotracheal tubes for a shorter period of time.
This was a carefully planned, well carried out, rigorously described and reported study, and its results are impressive: administration of steroids for 12 hours prior to planned extubation in patients who had been intubated for 2 days or more reduced the incidence of PELE seven-fold, and also reduced the need for reintubation. Given the seriousness of PELE and the magnitude of the benefit shown in this study, does this mean that the regimen used in this study should become a standard of care in our ICUs? Maybe, and maybe not, as influenced by several considerations.
Are the patients in this study similar enough to my patients, and is the authors' experience with PELE and the need for reintubation consistent with what is encountered in my institution? The patient population is well-described, so that readers can judge how well they match up to the patients intubated and ventilated in their ICUs. The more dissimilar the populations (for example, for a neurocritical care unit or one that sees mainly postoperative patients), the more caution would seem appropriate. Although the authors cite a previous study that found a 22% incidence of PELE, as observed in their trial, this seems high to me. Perhaps it is related to the care with which this complication was deliberately sought, and an 8% reintubation rate is probably reasonable.
What happens in everyday clinical practice (clinical effectiveness) often does not replicate what is found in the rigorous, carefully-controlled circumstances of a clinical trial (efficacy). How effectively could the regimen used in this study be implemented in my ICU? Here there may be some problems with ventilatory management and extubation as typically practiced in the United States.
Francois et al evaluated their patients in the evening and determined that they would be extubated the next morning, permitting them to administer the 12 hours of steroids before extubation at the usual time. In this country decisions to extubate, particularly after several days of mechanical ventilation for acute respiratory failure as with the patients in this study, are typically made on morning rounds and carried out promptly. This is consistent with the current standard of care. According to the most-often cited weaning recommendations, the 2001 international consensus guidelines,1 readiness for liberation from mechanical ventilation should be assessed using a spontaneous breathing trial; those who pass this trial should be extubated as soon as possible and not remain intubated any longer than is necessary. Numerous studies have confirmed the correlation between duration of intubation and the incidence of ventilator-associated pneumonia and other complications. The need to wait 12 hours in order to administer a course of methylprednisolone might lead to extubation during the night shift, when staffing may be less and observation for post-extubation difficulties harder to maintain, or holding the patient over until the next morning, essentially adding another day of intubation time.
If the decision to extubate is made based on the results of an early-morning assessment, could the protocol be abbreviated in order to get the tube out in the next several hours, administering only 2 or 3 doses of steroids beforehand? This question cannot be answered at present. And what if, on reassessment prior to extubation, the decision is made to defer extubation after the steroid course has already begun, as happened a few times during the study and is not uncommon in the unit? Continuing the regimen and extubating the patient the next day would mean giving 200 mg of methylprednisolone rather than 80 mg, the safety and expense of which might become problematic.
Certainly, patients with a history of PELE should receive methylprednisolone prior to planned extubation. Those patients whom the clinician suspects to be at especially high risk for PELE—which according to this study would include small women with large tubes, especially those admitted after trauma—would be good candidates as well. As to whether all other patients who will have been intubated for 2 days or more and do not have a specific contraindication should receive steroids prior to extubation—as is recommended in the editorial accompanying the Francois study2—I think the jury is still out. I am inclined to await further confirmation of this trial before introducing this regimen this broadly into my own ICU practice.