Effect of nocturnal EPAP titration to abolish tidal expiratory flow limitation in COPD patients with chronic hypercapnia: a randomized, cross-over pilot study.

BACKGROUND: Tidal expiratory flow limitation (EFLT) promotes intrinsic PEEP (PEEPi) in patients with chronic obstructive pulmonary disease (COPD). Applying non-invasive ventilation (NIV) with an expiratory positive airway pressure (EPAP) matching PEEPi improves gas exchange, reduces work of breathing and ineffective efforts. We aimed to evaluate the effects of a novel NIV mode that continuously adjusts EPAP to the minimum level that abolishes EFLT. METHODS: This prospective, cross-over, open-label study randomized patients to one night of fixed-EPAP and one night of EFLT-abolishing-EPAP. The primary outcome was transcutaneous carbon dioxide pressure (PtcCO2). Secondary outcomes were: peripheral oxygen saturation (SpO2), frequency of ineffective efforts, breathing patterns and oscillatory mechanics. RESULTS: We screened 36 patients and included 12 in the analysis (age 72 ± 8 years, FEV1 38 ± 14%Pred). The median EPAP did not differ between the EFLT-abolishing-EPAP and the fixed-EPAP night (median (IQR) = 7.0 (6.0, 8.8) cmH2O during night vs 7.5 (6.5, 10.5) cmH2O, p = 0.365). We found no differences in mean PtcCO2 (44.9 (41.6, 57.2) mmHg vs 54.5 (51.1, 59.0), p = 0.365), the percentage of night time with PtcCO2 > 45 mm Hg was lower (62(8,100)% vs 98(94,100)%, p = 0.031) and ineffective efforts were fewer (126(93,205) vs 261(205,351) events/hour, p = 0.003) during the EFLT-abolishing-EPAP than during the fixed-EPAP night. We found no differences in oxygen saturation and lung mechanics between nights. CONCLUSION: An adaptive ventilation mode targeted to abolish EFLT has the potential to reduce hypercapnia and ineffective efforts in stable COPD patients receiving nocturnal NIV. TRIAL REGISTRATION: ClicalTrials.gov, NCT04497090. Registered 29 July 2020-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04497090 .

Prevalence and variability of use of home mechanical ventilators, positive airway pressure and oxygen devices in the Lombardy region, Italy.

Few studies have analyzed the prevalence and accessibility of home mechanical ventilation (HMV) in Italy. We aimed to investigate the prevalence and prescription variability of HMV as well as of long-term oxygen therapy (LTOT) and continuous positive airway pressure (CPAP), in the Lombardy Region. Prescribing rates of HMV (both noninvasive and tracheostomies), CPAP (auto-CPAP, CPAP/other sleep machines) and LTOT (liquid-O2, O2-gas, concentrators) in the 15 Local Healthcare districts of Lombardy were gathered from billing data for 2012 and compared. Crude rates (per 100,000 population) and rates for the different healthcare districts were calculated. In 2012, 6325 patients were on HMV (crude prescription rate: 63/100,000) with a high variation across districts (8/100,000 in Milano 1 vs 150/100,000 in Pavia). There were 14,237 patients on CPAP (crude prescription rate: 142/100,000; CPAP/other sleep machines 95.3% vs auto-CPAP 4.7%) with also high intra-regional variation (56/100,000 in Mantova vs. 260/100,000 in Pavia). There were 21,826 patients on LTOT (prescription rate: 217/100,000 rate; liquid-O2 94%, O2-gas 2.08%, O2-concentrators 3.8%), with again high intra-regional variation (100/100,000 in Bergamo vs 410/100,000 in Valle Camonica). The crude rate of HMV prescriptions in Lombardy is very high, with a high intra-regional variability in prescribing HMV, LTOT and CPAP which is partly explainable by the accessibility to specialist centers with HMV/sleep-study facilities. Analysis of administrative data and variability mapping can help identify areas of reduced access for an improved standardization of services. An audit among Health Payer and prescribers to interpret the described huge variability could be welcomed.

A case of obstructive sleep apnea syndrome associated with floppy eyelid syndrome: positive effect of CPAP therapy.

The obstructive sleep apnoea syndrome (OSAS) may be associated with several eyes disorders, among which the most common is the floppy eyelid syndrome (FES). We intended to highlight the association between OSAS and FES and evaluate the effect of FES treatment with Continuous Positive Airway Pressure (CPAP). A 50-year patient with a 10-year history of snoring, sleep fragmentation and daytime sleepiness associated with several comorbidities has been studied. For six months, several ocular symptoms were present, particularly on waking up in the morning. An overnight respiratory polygraphy was performed at baseline and after CPAP titration. The treatment with CPAP corrects apnea/hypopnea events and rapidly improves patient's daytime sleepiness and eyes FES-related symptoms. This improvement is already evident after a very short period of treatment.

End-of-Life Discussion, Patient Understanding and Determinants of Preferences in Very Severe COPD Patients: A Multicentric Study.

Discussion about patients' end-of-life (E-o-L) preferences should be part of the routine practice. Using a semi-structured interview with a scenario-based decision, we performed a prospective multicentre study to elicit the patients' E-o-L preferences in very severe chronic obstructive pulmonary disease (COPD). We also checked their ability to retain this information and the respect of their decisions when they die. Forty-three out of ninety-one of the eligible patients completed the study. The choice of E-o-L practice was equally distributed among the three proposed options: endotracheal intubation (ETI), 'ceiling' non-invasive ventilation (NIV), and palliation of symptoms with oxygen and morphine. NIV and ETI were more frequently chosen by patients who already experienced them. ETI preference was also associated with the use of anti-depressant drugs and a low educational level, while a higher educational level and a previous discussion with a pneumologist significantly correlated with the preference for oxygen and morphine. Less than 50% of the patients retained a full comprehension of the options at 24 hours. About half of the patients who died in the follow-up period were not treated according to their wishes. In conclusion, in end-stage COPD more efforts are needed to improve communication, patients' knowledge of the disease and E-o-L practice.

Tele-assistance in chronic respiratory failure: patients' characterization and staff workload of 5-year activity.

BACKGROUND: The issue of how to optimize the routine use of tele-assistance (TA) in the clinical care remains to be addressed. Skills and costs of human resources represent the major component to care for chronic patients with TA. METHODS: We investigated (1) the change in patient population, mortality, and staff utilization/cost during the first 5-year activity of a TA program (24-h availability of a call center, pulse oxygen device, and second medical opinion) dedicated to chronic respiratory failure patients and (2) the staff time dedicated to each new patient admitted to the service. RESULTS: Three-hundred and ninety-six patients (age 64 +/- 17 years; 296 men) were reviewed across 5 years of activity. Patients followed/year increased over time, particularly for amyotrophic lateral sclerosis subjects. Calls/month dramatically increased from 60 to 290, with a 5-year number of calls equal to 12.952. The doctor's time dedicated to TA decreased over time, whereas the nurse's time increased allowing a cost saving of 39% when compared with budgeted salary costs. The number of home ventilated patients did not change, remaining over 78%. The mortality rate increased over time (from 6% to 11%). Both chronic obstructive pulmonary disease (COPD) and No-COPD patients used the TA service more frequently during the winter, and COPD used it also in the summer. CONCLUSIONS: A stable TA service dedicated to chronic respiratory failure may be reached after 4 years. Across years, (1) number of patients increased, with COPD and ventilated subjects being the most representative; (2) calls varied during seasons; (3) doctor's workload decreased, saving salary costs; and (4) each new enrolled patient may require 73 and 27 min/month of nurse and doctor, respectively.

Automatic tailoring of the lowest PEEP to abolish tidal expiratory flow limitation in seated and supine COPD patients.

RATIONALE: In COPD patients, the development of tidal expiratory flow limitation (EFLT) results in intrinsic positive end-expiratory pressure (PEEPi), leading to increased work of breathing and worsening patient-ventilator interaction. An external PEEP can mitigate these consequences, but how to optimize its value it is still unknown. OBJECTIVE: To measure the minimum PEEP able to abolish EFLT by a new automatic non-invasive ventilation (NIV) mode in stable hypercapnic COPD patients in the seated and supine positions. METHODS: Twenty-six hypercapnic COPD patients (mean±SD: FEV1%pred = 39.2 ±â€¯16.1, FEV1/FVC%pred = 46.3 ±â€¯16.3%) were studied while receiving NIV during two consecutive 15-min periods, with patients studied seated in the first and supine in the second. A ventilator able to identify EFLT breath-by-breath by using the forced oscillation technique optimized in real-time PEEP to the lowest pressure able to abolish EFLT (PEEPO). RESULTS: The ventilator was always able to identify a PEEPO. Its values were highly variable among patients and increased from median(iqr) 4.0 (0.03) (range: 4.0-8.3cmH2O) to 6 (6.1) cmH2O (range: 4.0-15.7 cmH2O) when patients moved from the seated to the supine position, respectively. PEEPO in supine position did not correlate to any spirometric or anthropometric variable. CONCLUSIONS: PEEPO in COPD patients is highly variable and increases in supine position. It is not predicted by spirometric nor anthropometric variables, but had a considerable variability among the patients. We suggest that PEEPo may be used as a phenotyping variable in COPD patients.

Does 6-Month Home Caregiver-Supervised Physiotherapy Improve Post-Critical Care Outcomes?: A Randomized Controlled Trial.

OBJECTIVE: This study aims to determine whether a 6-month home physiotherapy program can improve outcomes in critical care survivors. DESIGN: Forty-eight consecutive patients were randomized. The treatment group underwent 2 sessions/day of breathing retraining and bronchial hygiene, physical activity (mobilization, sit-to-stand gait, limb strengthening), and exercise re-conditioning whereas controls underwent standard care. Maximum inspiratory/expiratory pressures (MIP/MEP), forced volumes, blood gases, dyspnea, respiratory rate, disability, peripheral force measurements, perceived health status (Euroquol-5D), patient adherence/satisfaction, safety, and costs were assessed. RESULTS: Outcomes of treatment versus controls: MIP 14 ± 17 vs. -0.2 ± 14 cm H2O, MEP 27 ± 27 vs. 6 ± 21 cm H2O both P < 0.03; in addition, quality of life (Euroquol-5D) (P = 0.04), FEV1 (P = 0.03), dyspnea (P = 0.002), and respiratory rate (P = 0.009) were significantly improved for treated cardiorespiratory patients only. Eighty-three percent of the treated patients were decannulated versus 14% of controls (P = 0.01). Compliance was high (74 ± 25%) and there were no side effects. The majority (87.4%) expressed satisfaction with the program. Treatment cost was 459&OV0556;/patient/month. CONCLUSIONS: Carrying over regular bronchial hygiene techniques, physical activity, and exercise into the home after long critical care stays is safe and has a beneficial effect on respiratory muscles, decannulation, pulmonary function, and quality of life.

Effects of acute on chronic respiratory failure on hypercapnia and 3-month survival.

BACKGROUND: There is a lack of information on respiratory function and mechanics after COPD exacerbations. STUDY OBJECTIVES: To find their role in short-term survival and occurrence of chronic hypercapnia after these events. PATIENTS AND INTERVENTIONS: Seventy-three COPD patients recovering from a recent severe exacerbation underwent evaluation of breathing pattern, breathing mechanics, lung function, and arterial blood gas levels at the time of discharge from a respiratory ICU (RICU). RESULTS: The 3-month mortality rate after RICU discharge was 11%. The percent of ideal body weight (%IBW) [R = 6.04; p = 0.01] and occlusion pressure (R = 5.41; p = 0.02) provided significant distinction between deceased patients and survivors; the final discriminant equation showed that %IBW was able to predict patient death or survival with an accuracy of 90%. With decreasing order of power, the ratio of inspiratory time to total breathing cycle time (Ti/Ttot) [R = 8.87; p = 0.003], pressure-time product of the inspiratory muscles (R = 7.12; p = 0.009), maximal esophageal pressure (R = 6.00; p = 0.01), esophageal pressure (R = 5.50; p = 0.02), Pa(O2)/fraction of inspired oxygen (R = 4.72; p = 0.03), and pressure time index (PTI) [R = 4.57; p = 0.03] provided a significant distinction between hypercapnia and normocapnia at discharge. The discriminant equation, including Ti/Ttot and PTI, could correctly separate hypercapnic or normocapnic patients with an accuracy of 76%. CONCLUSIONS: In COPD patients who are recovering from a severe exacerbation, hypercapnia is strongly related to inspiratory muscle work, strength, and breathing pattern; and only body weight predicts short-term survival.

Physiological effects of meals in difficult-to-wean tracheostomised patients with chronic obstructive pulmonary disease.

OBJECTIVES: To evaluate effects of meals in difficult-to-wean tracheostomised patients with chronic obstructive pulmonary diseases during spontaneous breathing or Inspiratory Pressure Support. DESIGN: Prospective, crossover, randomised, and physiological study. SETTING: Weaning centre. PATIENTS: Sixteen COPD undergoing either decreasing levels of pressure support or increasing periods of spontaneous breathing. MEASUREMENTS: Each patient underwent monitoring during a 30-min procedure, during and after meals either under pressure support or spontaneous breathing on two consecutive days. Inductance plethysmography was used to monitor respiratory rate and tidal volume. Tidal volume by a flow transducer, arterial oxygen saturation, pulse rate, end-tidal CO2(,) and dyspnoea by a visual analogue scale were also assessed. RESULTS: ANOVA analysis showed a significant increase under spontaneous breathing for respiratory rate (P<0.001) and for end tidal CO(2) (P<0.03) induced by the meals. Inspiratory pressure support was associated to significantly greater tidal volume (P<0.001), lower respiratory rate (P<0.032), lower respiratory rate/tidal volume (P<0.001), and lower pulse rate (P<0.047) than spontaneous breathing. Under spontaneous breathing but not under pressure support a statistically worsening in meal-induced dispnoea (P<0.001) was found. CONCLUSIONS: In tracheostomised difficult-to-wean COPD patients: 1) under unassisted breathing, meals may induce an increase in respiratory rate, end-tidal CO(2), and dyspnoea; 2) inspiratory pressure support ventilation prevents dyspnoea from worsening during meals.

Assessment of physiologic variables and subjective comfort under different levels of pressure support ventilation.

STUDY OBJECTIVES: To evaluate the effects of 12 ventilator settings (pressure support ventilation [PSV] plus positive end-expiratory pressure [PEEP], 30 + 0 cm H(2)O; 25 + 5 cm H(2)O; 25 + 0 cm H(2)O; 20 + 5 cm H(2)O; 20 + 0 cm H(2)O; 15 + 5 cm H(2)O; 15 + 0 cm H(2)O; 10 + 5 cm H(2)O; 10 + 0 cm H(2)O; 5 + 5 cm H(2)O; 5 + 0 cm H(2)O; and 0 + 5 cm H(2)O) on physiologic variables; the percentage of ineffective efforts; patient comfort; and whether the diagnosis of COPD may influence results. DESIGN: Prospective, randomized, physiologic study. SETTING: Three weaning centers. PATIENTS: Thirty-six consecutive patients (20 patients with COPD). INTERVENTION: Patients were randomly submitted to the 12 settings. MEASUREMENTS AND RESULTS: Breathing pattern, respiratory drive (p0.1), arterial oxygen saturation (Sato(2)), heart rate, percentage of ineffective efforts per minute, patient comfort measured by means of a visual analogue scale (VAS), and BORG scale were recorded under each setting. Under different levels of assistance, breathing pattern, Sato(2), and p0.1 significantly and linearly changed (p < 0.0001) while VAS and BORG scale presented a significant (p = 0.027) U-shaped trend; high or low assistance caused the most discomfort. Under high levels of assistance, a higher (analysis of variance, p = 0.023) frequency of ineffective effort percentage was observed in the subgroup of 26 patients who presented this phenomenon. Breathing pattern significantly (p = 0.013) changed when compared to PSV alone (PSV plus zero end-expiratory pressure [ZEEP]) at the same total inspiratory pressure assistance (PSV plus PEEP). A huge variability among patients in breathing pattern and comfort was found under the setting rated as the most comfortable by patients. The diagnosis of COPD did not influence the overall results. CONCLUSIONS: The following conclusions are made: (1) physiologic variables followed a linear trend, while comfort followed a U-shaped trend under different levels of PSV (irrespective of COPD diagnosis); (2) high assistance caused an increase in ineffective efforts; (3) only the breathing pattern significantly changed when total assistance was given as PSV plus PEEP when compared to PSV alone (PSV plus ZEEP); and (4) the extreme levels of PSV are not associated with the best comfort.

Tolerance and physiologic effects of nocturnal mask pressure support vs proportional assist ventilation in chronic ventilatory failure.

STUDY OBJECTIVES: To compare the tolerance and physiologic effects of a 5-night treatment with either nasal proportional assist ventilation (PAV) or pressure support ventilation (PSV) in patients with chronic ventilatory failure. DESIGN: Cross-over, randomized, controlled study. SETTING: Rehabilitation units of pneumology department. PATIENTS OR PARTICIPANTS: Four patients with COPD and 10 patients with restrictive thoracic diseases with chronic hypercapnia (median baseline Paco(2), 55.1 mm Hg) were studied. INTERVENTIONS: In a cross-over study, nasal PAV and PSV set at the patient's comfort were randomly applied during 5 consecutive nights (with a 2-night washout period). MEASUREMENTS AND RESULTS: Continuous nocturnal pulse oximetric saturation (Spo(2)) and arterial blood gas results at wake-up were evaluated at baseline during spontaneous breathing and on the fifth day of ventilatory support. Dyspnea, sleep quality, adaptation, and comfort at inspiration and expiration by visual analog scale (VAS) were evaluated every day as well as a side effects score. On the fifth day, there were no significant differences in daytime Paco(2) (median PAV, 53.3 mm Hg; median PSV, 50.2; p = 0.168). Mean nocturnal Spo(2) improved significantly with both PAV and PSV without any significant differences between modes (baseline median, 92%; PAV median, 94.5%; PSV median, 95%). The percentage of the study night spent < 90% Spo(2) (T90) was slightly but significantly higher with PAV than with PSV (median PAV T90, 4%; median PSV T90, 2%; p = 0.049). The VAS symptom score was similar at day 5 between modes; however, nasal and oral dryness were lower (p = 0.05) and alarm noise was higher (p = 0.037) with PAV. CONCLUSIONS: After 5 days of treatment, both modes had similar tolerance, and were equally effective in reducing daytime hypercapnia and improving nocturnal saturation and symptoms. However, PAV induced less nasal and oral dryness but was associated with higher alarm noise.

Comparison of five bilevel pressure ventilators in patients with chronic ventilatory failure: a physiologic study.

OBJECTIVE: To compare patient-ventilator interaction and comfort in patients with chronic ventilatory failure (CVF) who are undergoing noninvasive positive-pressure ventilation with five different commercial bilevel pressure home ventilators. Also, we wanted to evaluate the short-term effects of the five ventilators on physiologic variables, namely, breathing patterns and inspiratory muscles. DESIGN: Randomized, controlled physiologic study. SETTING: Pulmonary division of a rehabilitation institution. PATIENTS: Twenty-eight patients with CVF due to COPD (17 patients) and restrictive chest wall diseases (11 patients). MEASUREMENTS: Sensation of comfort, breathing patterns and minute ventilation (E), respiratory muscles and mechanics, and patient-ventilator interaction during both unassisted and assisted ventilation with the five ventilators applied randomly. RESULTS: The five ventilators showed different flow and pressure waveforms. The level of comfort was somehow different among the studied ventilators. When compared to unassisted ventilation, all ventilators induced a significant increase in E (p < 0.01) without any significant difference among ventilators. Use of the five ventilators resulted in significant differences in peak airway opening pressure (Pao,peak) but not in mean airway opening pressure computed over a period of 1 min (PTPao,min), and in a duty cycle. Ineffective efforts (IEs) were similar among the studied ventilators. In comparison with unassisted ventilation, all ventilators induced significant reductions in inspiratory muscle effort (p < 0.001). No significant relationship was found between level of comfort and PTPao,min, Pao,peak, or the number of IEs. CONCLUSIONS: In stable, awake patients with CVF, all of the studied ventilators were well-tolerated, although with a great intersubject variability in comfort, and performed well in terms of improvement in E and inspiratory muscle unloading, thus fulfilling the aims of mechanical ventilation. This effect was obtained with similar levels of PTPao,min, despite the fact that Pao,peak was different among some ventilators. The number of IEs was similar among the studied ventilators.

Effects of a multidisciplinary care program on disability, autonomy, and nursing needs in subjects recovering from acute respiratory failure in a chronic ventilator facility.

BACKGROUND: The aim of this study was to analyze the effects of a multidisciplinary program carried out in a chronic ventilator facility on disability, autonomy, and nursing needs of patients after a prolonged ICU stay. Secondary outcome measures were survival, weaning rate, chronic ventilator facility stay, and discharge destination. METHODS: Multidisciplinary assessment, clinical stabilization, weaning attempts, and a new Disabled Patients Autonomy Planning tool to assess daily care needs were investigated in 240 subjects in a chronic ventilator facility (52 subjects after cardiovascular surgery, 60 subjects with acute respiratory failure, 71 subjects with COPD, and 57 subjects with neurological disease). RESULTS: At admission, nursing needs, disability, and autonomy differed according to diagnosis (P < .001); weaned subjects had greater nursing needs (P < .001) and disability (P = .0014) than unweaned subjects. During the stay, 13.8% of the subjects died irrespective of diagnosis (P = .12); 47% (P < .001) were weaned with significant differences (P <.007) by diagnosis. In the 207 surviving subjects, nursing needs increased as disability increased (r = 0.59, P < .001) and autonomy decreased (r = -0.66, P < .001); disability and autonomy were inter-related (r = 0.61, P < .001). Oxygen saturation, hypercapnia, dyspnea, disability, autonomy, and nursing needs significantly improved (all, P < .001). Fifty-nine percent of the subjects were discharged home. Subjects discharged to nursing homes presented mainly neurological diseases, being more disabled and less autonomous, with higher nursing needs (all, P < .04). Mechanical ventilation use and tracheostomy increased the probability of being discharged to a nursing home (odds ratio [OR] of 1.84, P = .04; OR 2.47, P = .003, respectively). Mortality was higher in subjects who were ventilated (OR 8.44, P < .001), male (OR 2.64, P = .01), elderly (P < .001), or malnourished (P = .01) and in subjects with low autonomy (P < .001), greater nursing needs (P = .002), and more severe disabilities (P = .04). CONCLUSIONS: A specialized tailored multidisciplinary program in subjects after an ICU stay contributed to recovery from disability, autonomy, and fewer nursing needs irrespective of diagnosis. Subjects discharged to a nursing home were the most severely disabled.

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.