ARMI News - Part 7

Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Statistical Methods

Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Statistical MethodsThe FVC values are only reported for adults because children often failed to complete the FVC maneuver correctly. Spirometry was performed (MicroLoop II; Micro Medical; Rochester, UK). The postbronchodilator FEV1 was measured at randomization, after 6 and 12 weeks, and then quarterly 30 min after inhaling terbutaline at 0.5 mg from dry powder inhaler, or 1 mg via pressurized metered-dose inhaler (Breathaire; Novartis Pharmaceuticals Corporation; East Hanover, NJ). The prebronchodilator FEV1 was measured at randomization and yearly thereafter. Here

Predicted normal values of FEV1 and FVC were calculated based on gender, age, and height at each visit. For male patients < 16.0 years old and for female patients < 15.0 years old, the prediction formulas of Quanjer at al were used, and race correction factors 1.00, 0.91, 0.87, and 0.88 were applied for white, Oriental, black, and other race, respectively. For male patients > 18.0 years old and female patients > 17.0 years old, predicted values were calculated from the official statement of the European Respiratory Society, and the race correction factors 1.00, 0.90, 0.87, and 0.85 were applied for white, Oriental, black, and other race, respectively. In the age range of 16.0 to 18.0 years for male and 15.0 to 17.0 years for female patients, predicted normal values were computed by linear (in age) interpolation between the two formulae.
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Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma: Materials and Methods

The effectiveness of early intervention of inhaled corticosteroids on asthma progression has yet to be established in recent-onset, persistent disease. Therefore, a large worldwide, long-term, doubleblind, placebo-controlled comparison of low doses of inhaled corticosteroids initiated within the first 2 years of a diagnosis of asthma, the Inhaled Steroid Treatment as Regular Therapy in Early Asthma (START) study, was undertaken to determine whether early intervention with low-dose inhaled budesonide in patients with persistent asthma would prevent severe asthma-related events and the accelerated decline in lung function. The main results of the START trial are reported elsewhere, including the initial analysis of the postbronchodilator FEV1, In this report, the first 3-year double-blind part of the study, examining the effects of early intervention on lung function, is described in more detail, with additional analysis.

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Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed Asthma

Effects of Early Intervention With Inhaled Budesonide on Lung Function in Newly Diagnosed AsthmaAsthma is identified by the presence of reversible airflow obstruction; however, irreversible airflow obstruction also develops in some asthmatic patients. Peat et al described a greater decline in lung function, as measured by height-adjusted FEV1, in a cohort of asthmatic patients when compared to normal subjects (50 mL/yr vs 35 mL/yr) followed up for 18 years. These observations have been confirmed by Lange et al,2 who reported on a Danish cohort followed up over 15 years, and by Sears et al in a New Zealand population-based birth cohort. The degree of loss in lung function has been shown to be related to asthma duration.
The mechanisms of the loss in FEV1 may result from the development of airway remodeling; however, no prospective studies have been conducted to test this hypothesis. Nonetheless, one study suggested that the decline in FEV1 may be related to the persistence of airway inflammation, albeit neutrophilic inflammation. Some studies have suggested that early treatment with inhaled corticosteroids may prevent the development of the accelerated decline in FEV1. read more

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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Recommendation

Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: RecommendationGender is shown to have little objective effect on polysomnography sleep architecture or sleep regulation. Women (age > 50 years) may have slightly better SWS preservation than men. Power spectral analysis has shown a small increase in delta, theta, and lower a frequencies in women compared with men… Normative data during illness will be needed to establish whether the increase in delta activity in these patients reflects cerebral dysfunction. Certainly in the IS group who were fully awake, alert, and responsive with minimal drug influence, cerebral dysfunction is less likely an etiology of increased delta activity. Source

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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Summary

Increased low amplitude delta waves may be related to septic encephalopathy. In the study by Cooper et al, septic encephalopathy was thought less likely due to negative blood culture results. However, in the study by Gabor et al, five of seven patients had positive blood culture findings, but SWS was only 2.7% of TST. Many of our patients had positive culture results (all sources), but only one patient had a positive blood culture result; no correlation existed with mDelta activity. It is well supported in the literature that 50% of patients admitted to the ICU with pneumonia do not have positive culture results, particularly if they have received antibiotics. Therefore, systemic inflammatory response to infection despite negative blood culture results cannot be eliminated. Cytokines released, specifically interleukin (IL)-1 and tumor necrosis factor (TNF), lead to an increase in delta activity. there

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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Conclusion

Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: ConclusionElectrolyte imbalance, liver failure, renal failure, anoxic-ischemic brain injury, drugs, and sepsis may all contribute to encephalopathy. None of our patients had neurologic signs that may be associated with encephalopathy, such as tremor, myoclonus, or asterixis. Four patients had an elevation, albeit slight, in serum creatinine, and three of them were in the IS group and were totally alert. Only two patients had an elevation (insignificant) in serum bilirubin. No patient had oxygen saturations < 90% or systolic BP < 90 mm Hg, which could be associated with anoxic or ischemic encephalopathy. Although the groups did not differ statistically between APACHE II scores, patients in the CS and CS/NMBA groups had higher a LIS, presence of ARDS, use of vasopressor agents, and higher mortality, indicating a sicker group of patients compared to the IS group. other

Severity of illness may account for the change in sleep pattern but was not significant due to the small sample size. A trend was noted in increasing TST and LIS and APACHE II scores, potentially indicating greater requirements for sleep with increasing severity of illness.
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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Causes

In their study, 6 of 11 patients had congestive heart failure likely contributing to the central apneas associated with PS ventilation. Our patient population consisted mainly of individuals with COPD and pneumonia leading to respiratory failure. Although none of our patients were receiving assist-control ventilation, 12 patients received SIMV with mechanical ventilator rates and there was no difference in arousals or awakenings compared with the 6 patients with PS or SIMV changed to PS ventilation. Our patients may have been more critically ill and were also receiving sedation, which may have contributed to the decreased effect of ventilator mode on sleep fragmentation.
All patients demonstrated increased delta activity. Until recently, studies have excluded patients who were receiving sedation or who were critically ill. Cooper and colleagues investigated sleep patterns in 20 critically ill patients receiving mechanical ventilation who received CS and describe a large proportion of patients with increased delta activity. Patients were retrospectively categorized into three patient groups based on the following EEG features: disrupted sleep (all stages of sleep were present); atypical sleep where abnormal sleep stage transition was present (absent stage 2 sleep); or the presence of coma (> 50% delta waves). canadian health and care mall

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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Causes

Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: CausesPatients were not quantitatively sleep deprived, but > 50% of sleep occurred during the daytime period, illustrating the disruption of nighttime sleep, alteration in normal circadian rhythm, and the importance of daytime sleep periods in preventing sleep depriva-tion. In contrast to the study of Gabor et al, in which REM sleep was determined to be normal, we found REM sleep to be severely reduced in the IS group and could not be comparatively analyzed with the other groups due to lack of detection in the patients receiving NMBAs, and only 50% of patients in the CS group had detectable REM. Decreased REM sleep observed in this study may have several causes, including use of vasopressor agents, narcotics, and increased difficulty in detecting REM in patient with neuromuscular blockade. further

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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Discussion

Nine patients had temperatures > 38.5°C, and five patients had temperatures < 36.8°C. When temperature was compared to sleep stage, again there was no correlation. It was noted that three of five patients with temperatures < 36.8°C had the lowest amount of mDelta activity. Too few patients had renal insufficiency and/or hyperbilirubinemia to perform an analysis on their effect on sleep architecture. There was no association between ventilator mode and arousals (p = 0.96) or awakenings (p = 0.78). PS and IMV/PS mode were combined, as only two patients received PS ventilation alone. Volume control/SIMV was analyzed independently and combined with pressure control/IMV. read

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Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: Results

Sleep in Critically III Chemically Paralyzed Patients Requiring Mechanical Ventilation: ResultsThere was no statistical difference in delta activity for staging slow-wave sleep (SWS) between the two methods (p = 0.96). The Rechtschaffen and Kales scoring criteria resulted in 0%, 1%, and 5% reductions in staging SWS in the IS, CS, and CS/ NMBA groups, respectively. Further results are reported using the mDelta data. Fifty percent of the subjects in the CS group had > 80% mDelta activity, and the other 50% had < 8% mDelta. In the group receiving NMBA, only two subjects had < 30% mDelta activity. In the IS group, only one patient had > 30% mDelta activity that was also associated with superimposed a activity. This patient had the highest LIS, sedation, and narcotic dosage in the IS group. REM sleep was severely diminished in the IS group (3.6% TST) [Table 3]. fully

Data were not analyzed further, as only 50% of patients receiving CS had detectable REM and no REM was detectable in the patients receiving NMBA.
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