Tele-assistance in chronic respiratory failure patients: a randomised clinical trial.

Chronic respiratory patients requiring oxygen or home mechanical ventilation experience frequent exacerbations and hospitalisations with related costs. Strict monitoring and care have been recommended. The aim of the present study was to primarily evaluate reduction in hospitalisations and, secondly, exacerbations, general practitioner (GP) calls and related cost-effectiveness of tele-assistance (TA) for these patients. A total of 240 patients (101 with chronic obstructive pulmonary disease (COPD)) were randomised to two groups: an intervention group entered a 1-yr TA programme while controls received traditional care. No anthropometric and clinical differences were found between groups both in baseline and in mortality (18% for TA, 23% for controls). Compared with controls, the TA group experienced significantly fewer hospitalisations (-36%), urgent GP calls (-65%) and acute exacerbations (-71%). Only COPD patients, as a separate group, had fewer hospitalisations, emergency room admissions, urgent GP calls or exacerbations. Each patient referred to staff a mean+/-sd 36+/-25 times. After deduction of TA costs, the average overall cost for each patient was 33% less than that for usual care. In chronic respiratory failure patients on oxygen or home mechanical ventilation, a nurse-centred tele-assistance prevents hospitalisations while it is cost-effective. The chronic obstructive pulmonary disease group seems to have a greater advantage from tele-assistance.

[Can the new technologies of telemedicine applied to health help the caregiver?]. / Le nuove tecnologie telematiche applicate in sanità possono aiutare il caregiver?

During the last few years about the chronic patient assistance the tendency is to privilege the home care model, favouring the permanence of the patient in the familiar nucleus. This determines an always greater involvement in term of time and responsibility of the caregiver that is of the person who takes cure of the patient one worrying itself to answer to its physical needs, psychical and social. The burden of the family caregiver is in the consisting majority of the cases rather. The caregiver is therefore, with full rights, the other protagonist of the disease and it must be necessarily integrated in the assistance plan. The increase of the age associated to an increase of the prevalence of chronic pathologies, determines the necessity to plan new interventions on the territory. In chronic patients alternative assistance models, using telemedicine, seem to be effectives improving both clinical aspects and quality of the life. A new area of interest is delineated therefore that, through the new technologies of the ICT must define been involved the single roles of the operating ones in the participation program. The telemedicine seems to be a useful instrument in order to support patient and caregiver in facing the disease and reducing stress. In our model of domiciliary telesurveillance the patient, the caregiver, the family and all the sanitary figures are been involved. This model integrating the service dedicated to chronic pathology with telepsychology at home seems to give good result even if ulterior studies, above all in the long term, are need.

A pilot study of nurse-led, home monitoring for patients with chronic respiratory failure and with mechanical ventilation assistance.

We assessed the feasibility of telemedicine for home monitoring of 45 patients with chronic respiratory failure (CRF) discharged from hospital. The patients transmitted pulsed arterial saturation (pSat) data via a telephone modem to a receiving station where a nurse was available for a teleconsultation. A respiratory physician was also available. Scheduled and ad hoc appointments were conducted. Thirty-five patients were on home mechanical ventilation, 13 with invasive and 22 with non-invasive devices. The main diagnosis was chronic obstructive pulmonary disease (COPD). The follow-up period was 176 days (SD 69). In all, 376 calls for scheduled consultations were received and 83 ad hoc consultations were requested by the patients. The actions taken were: 55 therapy modifications, 19 hospitalizations in a respiratory department for decompensated CRF, three hospitalizations in an intensive care unit (ICU), 22 requests for further investigations, 25 contacts with the general practitioner (GP), 66 demands for respiratory consultations and 10 calls for the emergency department. The mean time recorded for the 459 calls was 16 min/patient/week. In 82% of calls, a pSat recording was received successfully. The nurse time required to train the users in the operation of the pSat instrument was high (mean time 30 min). However, the results showed that home monitoring was feasible, and useful for titration of oxygen, mechanical ventilation setting and stabilization of relapses.

Cardiac event recording yields more diagnoses than 24-hour Holter monitoring in patients with palpitations.

Palpitation is a common symptom that sometimes results from a substantial cardiac arrhythmia. We compared the diagnostic yield of trans-telephonic event monitors with those of Holter monitoring in patients with intermittent palpitations. In all, 310 patients were randomly assigned to receive an event recorder or 24-hour Holter monitoring. Event recorders were used for seven days or until two recordings were obtained while symptoms occurred. The main end-point was an electrocardiogram (ECG) recorded during symptoms. The patients with palpitation recorded the one-lead ECG trace and sent it to a telemedicine call centre, where a nurse responded. There were 119 symptomatic patients in the event recorder group and 74 in the Holter group. The total costs were 6019 for event recording and 9605 for Holter monitoring. The average costs were 51 per symptomatic patient detected by event recorder monitoring and 130 per symptomatic patient detected by Holter monitoring. More patients therefore received a clear diagnosis, and more quickly, when using event recording than with Holter monitoring. For this reason, event recorders are preferable to Holter monitors for patients with palpitations.

Effect of home-based telecardiology on chronic heart failure: costs and outcomes.

Chronic heart failure (CHF) remains a common cause of disability. We have investigated the use of home-based telecardiology (HBT) in CHF patients. Four hundred and twenty-six patients were enrolled in the study: 230 in the HBT group and 196 in the usual-care group. HBT consisted of trans-telephonic follow-up and electrocardiogram (ECG) monitoring, followed by visits from the paramedical and medical team. A one-lead ECG recording was transmitted to a receiving station, where a nurse was available for reporting and interactive teleconsultation. The patient could call the centre when assistance was required (tele-assistance), while the team could call the patient for scheduled appointments (telemonitoring). The one-year clinical outcomes showed that there was a significant reduction in rehospitalizations in the HBT group compared with the usual-care group (24% versus 34%, respectively). There was an increase in quality of life in the HBT group (mean Minnesota Living Questionnaire scores 29 and 23.5, respectively). The total costs were lower in the HBT group (107,494 and 140,874, respectively). The results suggest that a telecardiology service can detect and prevent clinical instability, reduce rehospitalization and lower the cost of managing CHF patients.

Telecardiology: one-lead electrocardiogram monitoring and nurse triage in chronic heart failure.

We investigated a home-based intervention based on telecardiology in patients with chronic heart failure (CHF). Two hundred and thirty CHF patients, aged 59 years (SD 9), in stable condition and with optimized therapy were enrolled. The programme consisted of trans-telephonic follow-up and electrocardiogram (ECG) monitoring followed by visits from a paramedical and medical team. The patient could call the centre when required (tele-assistance), while the team could call the patient at prescheduled times (telemonitoring). During the first 12 months, there were 3767 calls (873 ad hoc and 2894 scheduled calls). There were 648 events, including 126 episodes of asymptomatic hypotension and 168 episodes which were not due to cardiological symptoms. No actions were taken by the nurse after 2417 calls (64%). A change in therapy was suggested after 418 calls, hospital admission in 62 patients, further investigations for 243 patients and a consultation with the general practitioner in 41 patients. A total of 2303 one-lead ECG recordings were received (10 per patient); 126 recordings (6%) were diagnosed as pathological in comparison with the baseline one. The one-lead ECG recording was used for titration of beta-blockers in 79 patients (mean dosage 38 mg vs 42 mg, P<0.01). Home telenursing could be an important application of telemedicine and single-lead ECG recording seems to offer additional benefit in comparison with telephone follow-up alone.

Role of telecardiology in the assessment of angina in patients with recent acute coronary syndrome.

We compared two models of assistance (telecardiology versus usual care) for patients discharged after acute coronary syndrome (ACS), in the assessment of angina. Two hundred patients were randomized into two groups at discharge for ACS: Group A to telecardiology and Group B to usual care. Early hospital readmission (in the first month) occurred in 16 patients (seven in Group A and nine in Group B). Six of Group A were readmitted for a cardiac cause (non-cardiac in one). Angina was the only cardiac cause. Five of the Group B patients were readmitted for a cardiac cause (non-cardiac in four). The results of the present study emphasize that patients with ACS suffer from a definite rate of cardiac symptoms within the first month (63%). Angina occurs more frequently within the first two weeks (68% of cases). Telecardiology slightly reduces hospital readmissions (telecardiology 44% versus usual care 56%), but better identifies true angina.

Decreased heart rate variability in patients with chronic obstructive pulmonary disease.

To evaluate possible autonomic nervous system (ANS) dysfunction in patients with chronic obstructive pulmonary disease (COPD) in the absence of any hypoxic neuronal damage, we studied 31 patients with COPD patients aged 31 to 68 years (55 +/- 10) and 32 age-matched healthy subjects (control). Respiratory function in the patients was as follows: FEV1 = 52 +/- 8 percent; PaO2 = 71 +/- 14 mm Hg; and PaCO2 = 40 +/- 10 mm Hg. The ANS was assessed by heart rate variability (HRV) in the time domain (SD of mean RR interval) and frequency domain (autoregressive spectral analysis recognizing low [LF] and high [HF] frequency components, vagal and sympathetic related, respectively). Patients and controls were evaluated at rest and during vagal (controlled breathing [CB]) and sympathetic (passive head-up tilt) maneuvers. Patients with COPD showed a depressed global HRV (rest SD = 34 +/- 20 ms vs 45 +/- 15 ms, p < 0.05; tilt SD = 28 +/- 14 ms vs 38 +/- 13, p < 0.01) with a predominant respiratory drive (rest HF = 44 +/- 28 vs 28 +/- 18, p < 0.05; tilt HF 42 +/- 28 vs 16 +/- 12, p < 0.01) as compared with normal subjects. In the control group, vagal and sympathetic responses were in opposite directions following a stimulus, whereas there was no significant HRV response in the COPD group. We conclude that patients with COPD have abnormalities of ANS function, with in particular a depressed HRV response to sympathetic and vagal stimuli.

Time course of pulmonary function before admission into ICU. A two-year retrospective study of COLD patients with hypercapnia.

Changes in cardiopulmonary function were retrospectively evaluated back to two years before acute exacerbations requiring ICU admission in 16 COLD patients with chronic hypercapnic respiratory insufficiency (age: 61 +/- 6 years, group A). Fifteen hypercapnic COLD patients matched for age, sex, lung function, and blood gas values not requiring an ICU admission in a period of two years, served as control subjects (age: 66 +/- 7, group B). Periodic assessments of spirometry, arterial blood gas values, echocardiography, body weight, and red blood cell count performed in stable state were compared for differences between groups and changes over a period of two years. The results indicated that basal body weight, rate of deterioration over time in FEV1, VC, blood gas values, bicarbonates, and RVD may be related to the necessity of ICU admission in COLD patients with hypercapnic respiratory insufficiency.

Acute exacerbations in severe COLD patients. Treatment using positive pressure ventilation by nasal mask.

We retrospectively evaluated the clinical effectiveness of a treatment schedule with intermittent positive pressure ventilation via nasal mask in 49 patients with acute exacerbations of COLD. According to the ability to successfully tolerate a preliminary trial with NIPPV, patients were submitted either to standard treatment plus NIPPV (25 patients) or to ST alone (24 patients). The ST consisted of medical, oxygen and physical therapy. The NIPPV was delivered by a volume cycled ventilator in control mode at least 4 h a day for five consecutive days a week, for three weeks. Comparison of baseline with measurements performed after 10 and 21 days of treatment respectively showed a significant improvement in PaO2 and in PaCO2 in both groups. After 21 days of treatment, VC, FEV1, inspiratory muscle strength, and dyspnea significantly improved in both groups. No significant difference was found between groups at any time of treatment. We conclude that the treatment schedule of NIPPV used is not more effective than ST alone in acute exacerbations of COLD.

Non-invasive modalities of positive pressure ventilation improve the outcome of acute exacerbations in COLD patients.

OBJECTIVE: 1) To compare the clinical usefulness of both non-invasive pressure support ventilation (NPSV) and non-invasive intermittent positive pressure ventilation in assist-control (A/C) mode (NIPPV) in chronic obstructive lung disease (COLD) patients with acute hypercapnic respiratory failure: 2) to compare retrospectively the usefulness of non-invasive mechanical ventilation (NMV) with standard medical therapy alone. DESIGN: Prospective randomized retrospective study. SETTING: 2 Respiratory intermediate intensive units. PATIENTS: 29 COLD patients (age: 62 +/- 8 years) with chronic respiratory failure were hospitalized in a department for rehabilitation during acute relapses of their disease. They were transferred to our intermediate intensive care unit (IICU) and submitted randomly to either NPSV (16 patients) or NIPPV (13 patients). MEASUREMENTS AND RESULTS: Blood gas analysis, dynamic flows, clinical variables, success rate, time of ventilation, side effects and subjective score of compliance to therapy. Therapy was considered successful when endotracheal intubation was avoided and patients were returned to their condition prior to exacerbation. No statistically significant difference was found between NPSV and NIPPV in success rate (NPSV 87.5%; NIPPV 77%) or in time of ventilation (NPSV: 69 +/- 49; NIPPV: 57 +/- 49 h). A better compliance to non-invasive mechanical ventilation (NMV) was found in NPSV patients than in NIPPV patients; side effects were observed less frequently in the NPSV group. Comparison of the success rate of NMV was retrospectively performed with 35 control COLD patients with chronic respiratory insufficiency who had undergone an acute relapse of their disease in the 2 years preceding the institution of the IICU and had been treated with oxygen and medical therapy alone. Patients submitted to NMV showed a greater success rate than control (82 versus 54%) after a period of ventilation ranging from 4-216 h. CONCLUSION: Non-invasive mechanical ventilation performed either by NPSV or NIPPV may improve the outcome of acute exacerbations of COLD, as compared to medical therapy alone. NPSV seems to be more acceptable to patients in comparison with NIPPV.

Is heart rate variability a reliable method to assess autonomic modulation in left ventricular dysfunction and heart failure? Assessment of autonomic modulation with heart rate variability.

Autonomic dysfunction seems to be involved in the progression and prognosis of congestive heart failure. Measurement of heart rate variability (HRV) provides a noninvasive method to obtain reliable and reproducible information on autonomic modulation of heart rate, but there is a difficulty in using HRV as a quantitative estimate of autonomic dysfunction in heart failure. This study was aimed at testing the hypothesis that abnormal modulation of heart rate assessed by power spectrum analysis may be present also in asymptomatic patients with left ventricular dysfunction and progress in patients with overt symptoms of congestive heart failure. HRV was measured in three groups of subjects: Group 1: 30 patients with chronic heart failure; Group 2: 21 patients with asymptomatic left ventricular dysfunction; and Group 3: 25 healthy volunteers as control group. HRV was evaluated by autoregressive spectral analysis with 600-beat ECG samples, while subjects were quietly recumbent (BSI), in conditions of controlled breathing (15 acts/min) (RSC) and passive orthostatism after tilting (80 degrees) (TLT). Patients in group 1 showed a reduction in the standard deviation of the R-R intervals (SDRR) (p<0.0003) and in the low frequency component (LF) (p<0.0001) compared to normal subjects. Low frequency component was not detectable in 11 patients of group I (p<0.0008). On RSC and TLT, group 1 failed to show any modification in the low frequency and high frequency components (HF) under any stimulation. Group 2 showed no modification at baseline evaluation, no increase in the high frequency component on RSC and in LF during TLT compared to controls (p<0.01 and p<0.0001 respectively). At baseline, group 1 had a lower SDRR (p<0.03) and LF (p<0.0001) vs. group 2, whereas during stimulation the two groups exhibited the same behaviour. In conclusion, reduced heart rate variability is specific for both asymptomatic and symptomatic post-ischemic left ventricular dysfunction. Our results suggest that frequency domain analysis of heart rate variability during a stimulation test allows a more accurate definition of the degree of autonomic control of heart rate.

[Telecardiology: a new way to manage the relation between hospital and primary care]. / Telecardiologia: una nuova modalità per gestire il territorio.

In medicine, computer-applied technology enables the performance of many diagnostic investigations with their transfer to a receiving station for referral. The use of telemedicine appears particularly promising in cardiovascular disease, because the cost/effectiveness ratio of an early, tailored intervention, in terms of life-saving and functional recovery, is demonstrated. The development of telemedicine represents an advantage for the individual patient in terms of the interaction between primary and secondary care. In addition, general practitioners can gain educationally and so be equipped to handle more advanced medical problems, thus reducing the number of hospital follow-up appointments. Economic savings for the health service are a driving force. Evidence to date is that the patient seems satisfied and the general practitioner gains competence, but the extent to which telemedicine results in reduced follow-up appointments and economic savings is not yet established. The findings of studies, even if preliminary, have important implications for the design and implementation of the telemedicine service center within the health care system. Selection of patients, significant service reorganization and provision of logistic support for the setting up and functioning of the telemedicine center will be required for it to operate efficiently. Future research in this subject needs to be more scientifically organized, in order to achieve informed decisions about the appropriate use of this technology.

Methacholine inhaled challenge: study of correlation among different indices expressing the result.

We tested measures of specific airway conductance (sGaw) and forced expiratory volume in one second (FEV1) versus transcutaneous oxygen tension (Ptc,O2) during inhaled methacholine bronchial challenge in 60 out-patients (38 males 22 females, mean age 33 +/- 13 yrs). The provocative doses of methacholine needed to produce a 35% decrease of sGaw (PD35,sGaw), a 20% fall in FEV1 (PD20,FEV1) and a 20% decrease in Ptc,O2 (PD20,O2) were simultaneously derived from the dose-response curves. Two groups were identified according to the PD20,FEV1 result ("responders" with a PD20,FEV1 < 2,000 micrograms methacholine and "nonresponders" with PD20,FEV1 > 2,000 micrograms methacholine). All three indices derived from the dose-response curves differed significantly between the groups (p < 0.00005). The relationship analysis showed a significantly better value for PD20,O2 versus PD35,sGaw (r = 0.98) than versus PD20, FEV1 (r = 0.62). We observed similar baseline levels and variations in arterial oxygen tension (Pa,O2) and Ptc,O2 during methacholine challenge (-25 and -27%, respectively) in 14 randomly studied responders. Thus, inhaled methacholine-induced hypoxaemia (PD20,O2) seems to reflect PD35,sGaw better than changes in FEV1. Our investigation supports the hypothesis that PD20,O2 could be useful in interpreting the methacholine inhaled challenge. It could be of help in clarifying the pathophysiological meaning of the concurrent hypoxaemia during this challenge, which should be further elucidated.

Telemedicine: a new frontier for effective healthcare services.

Telemedicine can be defined as the delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of healthcare providers, all in the interest of advancing the health of individuals and their communities. Such a wide definition includes many health care activities and a large number of applications have been tried, with variable degrees of interaction between all the players in the health care system. This review, starting from the need and opportunity that we are now facing to capitalize the great technological improvements in the field of information and communication technologies to improve also our health services, will illustrate the history, classification and main field of application of Telemedicine. Lastly, the available data on the application of Telemedicine for patients with respiratory diseases will be reviewed.

Cardiopulmonary intermediate intensive unit: time course of two years activity.

Intermediate intensive care may be defined as a post comprehensive programme, where monitoring, combined with necessary treatment, improves and maintains physiological functions to complete the cure of underlying diseases. The aims of this paper are: 1) to describe the caring activity that patients admitted to our 12 bed Cardiopulmonary Intermediate Intensive Unit (CPIIU) experience and, 2) to demonstrate that a noninvasive choice does not worsen mortality and the quality of care needed to improve patient outcome. From September 1st 1990 to September 30th 1992, 775 patients (135 respiratory subjects) were admitted. The majority of these patients came from Coronary Intensive Units or Medical and Surgical Intensive Care Units. Noninvasive cardiorespiratory monitoring was assessed in these patients, to obtain their clinical improvement. After this post acute observance, our patients were followed during a stabilization programme in the cardiopulmonary rehabilitation division until a day-hospital or home care programme was carried out. By implementing the CPIIU principles in our department we have reduced the number of deaths and the necessity for Intensive Care Unit admission (from 19 to 9.6%). The estimated risk of death proposed by Apache score was higher than that recorded in our patients (estimated Apache = 25 and 6% for respiratory and cardiac patients, respectively; actual Apache = 10.4 and 3.1% for the same patients, respectively). Average hospitalisation days in our CPIIU was 18 +/- 9. Our CPIIU showed a mean daily cost for each patient of $370.6.(ABSTRACT TRUNCATED AT 250 WORDS)

An unusual increase in haemodynamic values in a sleep apnoea syndrome patient with prolonged apnoea.

This case report shows the results of a right heart catheterisation in a patient with sleep apnoea syndrome (SAS). Arterial oxygen saturation (SaO2), heart rate, oronasal flow, and monitoring of electroencephalographic (EEG), sovrayoidal electromyographic (EMG) and thoracoabdominal movements were recorded simultaneously. A mixed apnoea of 180 s was registered, SaO2 fell to 54% and systolic pulmonary artery pressure (sPAP) increased to 130 mmHg. Slowly, haemodynamic values began to normalise with the reappearance of respiratory acts. We can hypothesize that this patient's nocturnal apnoeas may cause frequent and deep negative pleural pressure swings, with severe continuous action on pulmonary circulation. This case report has shown that a SAS patient is capable of developing an adaptative response to an unusual and remarkable systolic pulmonary artery pressure increase, which is mainly due to hypoxic vasoconstriction.

Respiratory and haemodynamic modifications during right heart catheterization in COLD patients.

Noninvasive measurement of the systolic time intervals is a routine procedure for the determination of myocardial performance, even in subjects without clinical or electrocardiographic signs of cardiopathy. Statistically significant differences in pre-ejection period (PEP) and PEP/left ventricular ejection time (LVET) between days and between observations were demonstrated by Levi et al. A high correlation between systolic time intervals and catecholamines was recorded. The aim of the present study was to evaluate the spontaneous modifications in pulmonary and cardiac parameters during a stressful situation, such as right heart catheterization. Seventeen patients with chronic obstructive lung disease (COLD) underwent right heart catheterization. Heart rate (HR), systemic artery pressure (SAP), pulmonary artery pressure (PAP), cardiac output (Q'c), cardiac index (CI), systolic stroke volume (SV), respiratory rate (RR), minute ventilation (V'E), oxygen consumption (V'O2), carbon dioxide production (V'CO2), their ratio (RQ), arterial and venous O2 and CO2, systolic time intervals (total electromechanical interval (QS2), LVET, PEP, PEP/LVET), total pulmonary resistance (TPR), adrenaline (A), and noradrenaline (NA) were recorded at the beginning of the test and 20, 40, 60 and 80 min thereafter. Analysis of variance (ANOVA) showed significant differences between the observations for systolic pulmonary artery pressure (SPAP), Q'c, V'O2, V'CO2, V'E, PEP/LVET, and NA. In conclusion, it is necessary to take into account spontaneous modifications in pulmonary haemodynamic parameters following a stressful situation, such as a catheterization, when studying the effects of drugs such as vasodilators and vasoactive agents.