High frequency chest wall oscillation for asthma and chronic obstructive pulmonary disease exacerbations: a randomized sham-controlled clinical trial.

BACKGROUND: High frequency chest wall oscillation (HFCWO) is used for airway mucus clearance. The objective of this study was to evaluate the use of HFCWO early in the treatment of adults hospitalized for acute asthma or chronic obstructive pulmonary disease (COPD). METHODS: Randomized, multi-center, double-masked phase II clinical trial of active or sham treatment initiated within 24 hours of hospital admission for acute asthma or COPD at four academic medical centers. Patients received active or sham treatment for 15 minutes three times a day for four treatments. Medical management was standardized across groups. The primary outcomes were patient adherence to therapy after four treatments (minutes used/60 minutes prescribed) and satisfaction. Secondary outcomes included change in Borg dyspnea score (≥ 1 unit indicates a clinically significant change), spontaneously expectorated sputum volume, and forced expired volume in 1 second. RESULTS: Fifty-two participants were randomized to active (n = 25) or sham (n = 27) treatment. Patient adherence was similarly high in both groups (91% vs. 93%; p = 0.70). Patient satisfaction was also similarly high in both groups. After four treatments, a higher proportion of patients in the active treatment group had a clinically significant improvement in dyspnea (70.8% vs. 42.3%, p = 0.04). There were no significant differences in other secondary outcomes. CONCLUSIONS: HFCWO is well tolerated in adults hospitalized for acute asthma or COPD and significantly improves dyspnea. The high levels of patient satisfaction in both treatment groups justify the need for sham controls when evaluating the use of HFCWO on patient-reported outcomes. Additional studies are needed to more fully evaluate the role of HFCWO in improving in-hospital and post-discharge outcomes in this population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00181285.

Excessive tidal volume from breath stacking during lung-protective ventilation for acute lung injury.

RATIONALE: Low tidal volume ventilation strategies for patients with respiratory failure from acute lung injury may lead to breath stacking and higher volumes than intended. OBJECTIVE: To determine frequency, risk factors, and volume of stacked breaths during low tidal volume ventilation for acute lung injury. DESIGN, SETTING, AND PATIENTS: Prospective cohort study of mechanically ventilated patients with acute lung injury (enrolled from August 2006 through May 2007) treated with low tidal volume ventilation in a medical intensive care unit at an academic tertiary care hospital. INTERVENTIONS: Patients were ventilated with low tidal volumes using the Acute Respiratory Distress Syndrome Network protocol for acute lung injury. Continuous flow-time and pressure-time waveforms were recorded. The frequency, risk factors, and volume of stacked breaths were determined. Sedation depth was monitored using Richmond agitation sedation scale. MEASUREMENTS AND MAIN RESULTS: Twenty patients were enrolled and studied for a mean 3.3 +/- 1.7 days. The median (interquartile range) Richmond agitation sedation scale was -4 (-5, -3). Inter-rater agreement for identifying stacked breaths was high (kappa 0.99, 95% confidence interval 0.98-0.99). Stacked breaths occurred at a mean 2.3 +/- 3.5 per minute and resulted in median volumes of 10.1 (8.8-10.7) mL/kg predicted body weight, which was 1.62 (1.44-1.82) times the set tidal volume. Stacked breaths were significantly less common with higher set tidal volumes (relative risk 0.4 for 1 mL/kg predicted body weight increase in tidal volume, 95% confidence interval 0.23-0.90). CONCLUSION: Stacked breaths occur frequently in low tidal volume ventilation despite deep sedation and result in volumes substantially above the set tidal volume. Set tidal volume has a strong influence on frequency of stacked breaths.