High-Flow Oxygen Therapy During Exercise Training in Patients With Chronic Obstructive Pulmonary Disease and Chronic Hypoxemia: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The study aimed to evaluate whether high-flow oxygen therapy (HFOT) during training was more effective than oxygen in improving exercise capacity in hypoxemic chronic obstructive pulmonary disease (COPD). METHODS: A total of 171 patients with COPD and chronic hypoxemia were consecutively recruited in 8 rehabilitation hospitals in a randomized controlled trial. Cycle-ergometer exercise training was used in 20 supervised sessions at iso inspiratory oxygen fraction in both groups. Pre- and post-training endurance time (Tlim), 6-minute walking distance (6MWD), respiratory and limb muscle strength, arterial blood gases, Barthel Index, Barthel Dyspnea Index, COPD Assessment Test, Maugeri Respiratory Failure questionnaire, and patient satisfaction were evaluated. RESULTS: Due to 15.4% and 24.1% dropout rates, 71 and 66 patients were analyzed in HFOT and Venturi mask (V-mask) groups, respectively. Exercise capacity significantly improved after training in both groups with similar patient satisfaction. Between-group difference in post-training improvement in 6MWD (mean: 17.14 m; 95% CI = 0.87 to 33.43 m) but not in Tlim (mean: 141.85 seconds; 95% CI = -18.72 to 302.42 seconds) was significantly higher in HFOT. The minimal clinically important difference of Tlim was reached by 47% of patients in the V-mask group and 56% of patients in the HFOT group, whereas the minimal clinically important difference of 6MWD was reached by 51% of patients in the V-mask group and 69% of patients in the HFOT group, respectively. CONCLUSION: In patients with hypoxemic COPD, exercise training is effective in improving exercise capacity. IMPACT STATEMENT: The addition of HFOT during exercise training is not more effective than oxygen through V-mask in improving endurance time, the primary outcome, whereas it is more effective in improving walking distance.

Baseline Exercise Tolerance and Perceived Dyspnea to Identify the Ideal Candidate to Pulmonary Rehabilitation: A Risk Chart in COPD Patients.

Background: The appropriate criteria for patient selection are still a key issue in the clinical management of patients referred to pulmonary rehabilitation (PR). Methods: We retrospectively analyzed the records of a wide population of 1470 outpatient or inpatients with chronic obstructive pulmonary disease (COPD) referred to standard PR at two specialized Italian centers. Two models of multivariate logistic regression were developed to test the predictive powers of baseline exercise tolerance, namely the distance walked in 6 mins (6MWD), and of baseline dyspnea on exertion, measured by the modified Medical Research Council scale (mMRC), versus the minimal clinically important difference (MCID) for the same outcomes. Results: Compared to the category of individuals with 6MWD >350 meters, those patients with 201-350 meters and ≤200 meters showed a higher probability (p<0.001) of predicting a MCID change. Compared to the category of individuals with mMRC 0-1point, all the other categories (2, 3, and 4) also showed a higher probability (p<0.001) of predicting a MCID change. The incorporation of baseline categories of 6MWD and mMRC in a risk chart showed that the percentage of patients reaching MCID in both variables increased as the baseline level of 6MWD decreased and of mMRC increased. Conclusion: This study demonstrates that lower levels of exercise tolerance and greater perceived dyspnea on exertion predict achieving clinically meaningful changes for both these treatment outcomes following PR. A specific risk chart that integrates these two variables may help clinicians to select ideal candidates and best responders to PR.

Functional recovery following physical training in tracheotomized and chronically ventilated patients.

BACKGROUND: Rehabilitation is a non-pharmacologic therapy that can restore health and reverse the patient's disability, but the efficacy of rehabilitation in critically ill patients is not well documented. METHODS: In a prospective cohort study, we assessed whether the degree of change in functional status after comprehensive rehabilitation influenced clinical outcomes in 77 tracheotomized patients (mean ± SD age 75 ± 7 y) admitted for difficult weaning to our regional weaning center. The care plan, including peripheral muscle training, was delivered daily. We recorded admission demographic, anthropometric, and functional characteristics. We measured the change in basic activities of daily living score (ΔBADL), survival, and weaning success rate as clinical outcomes. We performed the Pearson correlation analysis and linear regression, with ΔBADL as the dependent variable, to test the predictive power of the baseline measurements. RESULTS: Sixty-seven patients (87%) survived, and 55 of them (74%) succeeded in weaning during their stay in the weaning center. The mean ± SD ΔBADL improvement was 2.5 ± 2.0 points (median 2 points). Baseline performance of the latissimus dorsi predicted ΔBADL (ß = 0.388, 95% CI 0.111-1,664, P = .03). The probability of remaining ventilator-free (P = .043) and survival (P = .001) differed across the 4 ΔBADL categories (0 = no change, 1-2 = least improvement, and > 2 = improvement above median change). CONCLUSIONS: Mortality rate and weaning success differ according to ΔBADL following active rehabilitation/training in tracheotomized, ventilated, difficult-to-wean patients. The performance of the latissimus dorsi was the only significant predictor of change.

Patients' characterization, hospital course and clinical outcomes in five Italian respiratory intensive care units.

BACKGROUND: Respiratory intensive care units (RICU) dedicated to weaning could be suitable facilities for clinical management of "post-ICU" patients. METHODS: We retrospectively analyzed the time course of patients' characteristics, clinical outcomes and medical staff utilization in five Italian RICUs by comparing three periods of 5 consecutive years (from 1991 to 2005). RESULTS: A total of 3,106 patients (age 76 +/- 4 years; 72% males) were analyzed. The number of co-morbidities per patient (from 1.8 to 3.0, p = 0.05) and the previous intensive care unit (ICU) stay (from 25 to 32 days, p = 0.002) increased over time. The doctor-to-patient ratio significantly decreased over time (from 1:3 to 1:5, p < 0.01), whereas the physiotherapist-to-patient ratio mildly increased (from 1:6 to 1:4.5, p < 0.05). The overall weaning success rate decreased (from 87 to 66%, p < 0.001), and the discharge destination changed (p < 0.001) over time; fewer patients were discharged to home (from 22 to 10%), and more patients to nursing home (from 3 to 6%), acute hospitals (from 6 to 10%) and rehabilitative units (from 70 to 75%). The mortality rate increased over time (from 9 to 15%). Significant correlations between the doctor-to-patient ratio and the rates of weaning success (r = 0.679, p = 0.005), home discharge (r = 0.722, p = 0.002) and the RICU length of stay (LOS) (r = -0.683, p = 0.005) were observed. CONCLUSIONS: The clinical outcomes of our units worsened over 15 years, likely as consequence of admitting more severely ill patients. The potential further negative influence of reduced medical staff availability on weaning success, home discharge and LOS warrants future prospective investigations.

Subjective sleep quality during average volume assured pressure support (AVAPS) ventilation in patients with hypercapnic COPD: a physiological pilot study.

The aim of this short-term, single-blind, randomized, crossover study was to evaluate night-time efficacy of and compliance and physiological responses to average volume assured pressure support (AVAPS) versus pressure support (PS) ventilation. AVAPS or PS ventilation was delivered to nine stable hypercapnic COPD patients via a mask over two 5-day periods during consecutive weeks. The Synchrony ventilator was used to deliver mask ventilation as follows: 8 ml/kg of ideal body weight (as the targeted inspiratory tidal volume) with IPAP ranging from EPAP up to 30 cmH(2)O for AVAPS, and the patient's highest tolerated IPAP level for PS. EPAP was set at the minimum level for both modalities and oxygen was added at a fixed inspiratory fraction to maintain SaO(2) above 90%. Arterial blood gases, comfort (by VAS), and perceived sleep efficiency (SE by questionnaire) were measured at baseline (T0) and after three (T1) and five (T2) nights over the two periods. Compliance to ventilation, as measured by mean usage (hours/night), was also recorded. Measurements were similar between the two treatment periods at baseline. PaCO(2) and comfort VAS similarly improved for both modalities, whereas the SE score significantly improved at T2 with AVAPS (from 5.1 +/- 2.0 to 4.1 +/- 2.2, P = 0.001) but not with PS (from 5.1 +/- 1.7 to 4.7 +/- 1.3, P = 0.219). No difference in mean usage was found between the two modalities. Mask AVAPS is as comfortable and effective as PS at reducing respiratory acidosis but produces better perceived sleep efficiency in stable hypercapnic COPD patients.

Intrapulmonary percussive ventilation in tracheostomized patients: a randomized controlled trial.

OBJECTIVE: To investigate whether the addition of intrapulmonary percussive ventilation to the usual chest physiotherapy improves gas exchange and lung mechanics in tracheostomized patients. DESIGN AND SETTING: Randomized multicenter trial in two weaning centers in northern Italy. PATIENTS AND PARTICIPANTS: 46 tracheostomized patients (age 70 +/- 7 years, 28 men, arterial blood pH 7.436 +/- 0.06, PaO(2)/FIO(2) 238 +/- 46) weaned from mechanical ventilation. INTERVENTIONS: Patients were assigned to two treatment groups performing chest physiotherapy (control), or percussive ventilation (IMP2 Breas, Sweden) 10 min twice/day in addition to chest physiotherapy (intervention). MEASUREMENTS AND RESULTS: Arterial blood gases, PaO(2)/FIO(2) ratio, and maximal expiratory pressure were assessed every 5th day for 15 day. Treatment complications that showed up in 1 month of follow-up were recorded. At 15 days the intervention group had a significantly better PaO(2)/FIO(2) ratio and higher maximal expiratory pressure; after follow-up this group also had a lower incidence of pneumonia. CONCLUSIONS: The addition of percussive ventilation to the usual chest physiotherapy regimen in tracheostomized patients improves gas exchange and expiratory muscle performance and reduces the incidence of pneumonia.