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1.
Am J Crit Care ; 28(6): 424-432, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31676516

RESUMO

BACKGROUND: Morbidity and mortality after discharge from an intensive care unit appear to be higher in patients with sepsis than in patients without sepsis. OBJECTIVE: To evaluate morbidity and mortality in patients with and without sepsis within 2 years after intensive care unit discharge. METHODS: A prospective cohort study was conducted in 2 intensive care units. Patients who stayed in the intensive care unit longer than 24 hours were followed up for 2 years after discharge. Morbidity was assessed by using the Karnofsky scale, the Lawton instrumental activities of daily living scale, presence of pain, and readmissions. RESULTS: During the study, 74.7% of patients (859 of 1150; 242 with sepsis, 617 without sepsis) were discharged from the intensive care unit. Compared with patients without sepsis, patients with sepsis had higher mortality during follow-up (57.4% vs 34.2%; P < .001) and were 1.34 times as likely to die (per Cox regression). More patients with sepsis had pain (48.5% vs 35.2%, P = .003) and read-missions (65.5% vs 55.0%, P = .02). Patients with sepsis had a greater degree of functional loss, adjusted for confounding factors (mean [SD] change in Lawton scale score from intensive care unit admission to 2 years after intensive care unit discharge, 4.0 [8.0] vs 3.4 [8.2]; P = .31). CONCLUSION: Compared with patients without sepsis, those with sepsis have higher mortality in the intensive care unit and have more pain, hospital readmissions, and functional decline within 2 years after discharge.

4.
Nutr Clin Pract ; 2019 Oct 22.
Artigo em Inglês | MEDLINE | ID: mdl-31642115

RESUMO

This article presents 7 nutrition steps that, if not followed by the clinical staff, may be metaphorically considered as "7 deadly sins" of nutrition therapy. In this review, we suggest approaches that must be avoided or accomplished to increase compliance with the "Ten Commandments" of good nutrition practice in the intensive care setting. Multiple aggressive and simultaneous sets of therapies are implemented in the intensive care setting, which include nutrition and metabolic support as important components in these therapies. "Sins" should be remembered as a mnemonic device for nutrition standard care in the intensive care unit; this incorporates nutrition adequacy and protocol adherence.

5.
Respir Care ; 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31615923

RESUMO

BACKGROUND: Early mobilization is part of the rehabilitation process for critically ill patients and is currently considered a means of preventing ICU-acquired muscle deterioration and worsening of physical function. We sought to determine whether the use of speaking valves in tracheostomized patients would improve their mobility. We evaluated the changes in mobility performance with the use of speaking valves in tracheostomized subjects. METHODS: We performed a cohort study of a series of subjects who were tracheostomized and were being weaned from mechanical ventilation between April 2016 and May 2018. The subjects were those able to tolerate a speaking valve for a minimum of 30 min. Demographic data, comorbidities, cause of ICU admission, days in the ICU, duration of mechanical ventilation before tracheostomy, and days free from mechanical ventilation before tracheostomy were collected. Mobility status was evaluated using daily measurements of the Perme Intensive Care Unit Mobility Score. RESULTS: During the study period, 63 patients were tracheostomized. Patients with deficiencies in language (n = 2) or cognitive deficits (n = 36) and patients in exclusive palliative care (n = 7) were excluded. Eighteen subjects were enrolled in the study. The mean age of the subjects was 64.6 ± 14.2 y (55.5% were male), and the most common reason for ICU admission was pneumonia (n = 7; 38.8%). Perme scores increased from 11.3 (interquartile range 10.1-12.0) on the day before initiation of the speaking valve to 18.2 (IQR 16.2-20.1) immediately after the initiation of a speaking valve (P < .01). These changes were maintained during all periods of speaking valve use. CONCLUSION: The use of speaking valves in tracheostomized subjects improved mobility.

6.
Crit Care Med ; 2019 Oct 11.
Artigo em Inglês | MEDLINE | ID: mdl-31609775

RESUMO

OBJECTIVES: To identify the frequency, causes, and risk factors of early and late mortality among general adult patients discharged from ICUs. DESIGN: Multicenter, prospective cohort study. SETTING: ICUs of 10 tertiary hospitals in Brazil. PATIENTS: One-thousand five-hundred fifty-four adult ICU survivors with an ICU stay greater than 72 hours for medical and emergency surgical admissions or greater than 120 hours for elective surgical admissions. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The main outcomes were early (30 d) and late (31 to 365 d) mortality. Causes of death were extracted from death certificates and medical records. Twelve-month cumulative mortality was 28.2% (439 deaths). The frequency of early mortality was 7.9% (123 deaths), and the frequency of late mortality was 22.3% (316 deaths). Infections were the leading cause of death in both early (47.2%) and late (36.4%) periods. Multivariable analysis identified age greater than or equal to 65 years (hazard ratio, 1.65; p = 0.01), pre-ICU high comorbidity (hazard ratio, 1.59; p = 0.02), pre-ICU physical dependence (hazard ratio, 2.29; p < 0.001), risk of death at ICU admission (hazard ratio per 1% increase, 1.008; p = 0.03), ICU-acquired infections (hazard ratio, 2.25; p < 0.001), and ICU readmission (hazard ratio, 3.76; p < 0.001) as risk factors for early mortality. Age greater than or equal to 65 years (hazard ratio, 1.30; p = 0.03), pre-ICU high comorbidity (hazard ratio, 2.28; p < 0.001), pre-ICU physical dependence (hazard ratio, 2.00; p < 0.001), risk of death at ICU admission (hazard ratio per 1% increase, 1.010; p < 0.001), and ICU readmission (hazard ratios, 4.10, 4.17, and 1.82 for death between 31 and 60 days, 61 and 90 days, and greater than 90 days after ICU discharge, respectively; p < 0.001 for all comparisons) were associated with late mortality. CONCLUSIONS: Infections are the main cause of death after ICU discharge. Older age, pre-ICU comorbidities, pre-ICU physical dependence, severity of illness at ICU admission, and ICU readmission are associated with increased risk of early and late mortality, while ICU-acquired infections are associated with increased risk of early mortality.

7.
Rev Bras Ter Intensiva ; 31(3): 386-392, 2019.
Artigo em Português, Inglês | MEDLINE | ID: mdl-31618359

RESUMO

The improvement in cardiopulmonary resuscitation quality has reduced the mortality of individuals treated for cardiac arrest. However, survivors have a high risk of severe brain damage in cases of return of spontaneous circulation. Data suggest that cases of cardiac arrest in critically ill patients with non-shockable rhythms have only a 6% chance of returning of spontaneous circulation, and of these, only one-third recover their autonomy. Should we, therefore, opt for a procedure in which the chance of survival is minimal and the risk of hospital death or severe and definitive brain damage is approximately 70%? Is it worth discussing patient resuscitation in cases of cardiac arrest? Would this discussion bring any benefit to the patients and their family members? Advanced discussions on do-not-resuscitate are based on the ethical principle of respect for patient autonomy, as the wishes of family members and physicians often do not match those of patients. In addition to the issue of autonomy, advanced discussions can help the medical and care team anticipate future problems and, thus, better plan patient care. Our opinion is that discussions regarding the resuscitation of critically ill patients should be performed for all patients within the first 24 to 48 hours after admission to the intensive care unit.

8.
Rev. bras. ter. intensiva ; 31(3): 386-392, jul.-set. 2019.
Artigo em Português | LILACS-Express | ID: biblio-1042578

RESUMO

RESUMO A melhoria da qualidade da ressuscitação cardiopulmonar vem reduzindo a mortalidade dos indivíduos atendidos em parada cardiorrespiratória. Porém, os sobreviventes apresentam risco elevado de dano cerebral grave em caso de retorno à circulação espontânea. Dados sugerem que paradas cardiorrespiratórias, que ocorram em pacientes criticamente doentes com ritmos cardíacos não chocáveis, apresentem somente 6% de chance de retorno à circulação espontânea e, destes, somente um terço consiga recuperar sua autonomia. Optaríamos, assim, pela realização de um procedimento em que a chance de sobrevida é mínima, e os sobreviventes apresentam risco de aproximadamente 70% de morte hospitalar ou dano cerebral grave e definitivo? Valeria a pena discutir se este paciente é ou não ressuscitável, em caso de parada cardiorrespiratória? Esta discussão traria algum benefício ao paciente e a seus familiares? As discussões avançadas de não ressuscitação se baseiam no princípio ético do respeito pela autonomia do paciente, pois o desejo dos familiares e dos médicos, muitas vezes, não se correlaciona adequadamente aos dos pacientes. Não somente pela ótica da autonomia, as discussões avançadas podem ajudar a equipe médica e assistencial a anteciparem problemas futuros, fazendo-os planejar melhor o cuidado dos enfermos. Ou seja, nossa opinião é a de que discussões sobre ressuscitação ou não dos pacientes criticamente doentes devam ser realizadas em todos os casos internados na unidade de terapia intensiva logo nas primeiras 24 a 48 horas de internação.


Abstract The improvement in cardiopulmonary resuscitation quality has reduced the mortality of individuals treated for cardiac arrest. However, survivors have a high risk of severe brain damage in cases of return of spontaneous circulation. Data suggest that cases of cardiac arrest in critically ill patients with non-shockable rhythms have only a 6% chance of returning of spontaneous circulation, and of these, only one-third recover their autonomy. Should we, therefore, opt for a procedure in which the chance of survival is minimal and the risk of hospital death or severe and definitive brain damage is approximately 70%? Is it worth discussing patient resuscitation in cases of cardiac arrest? Would this discussion bring any benefit to the patients and their family members? Advanced discussions on do-not-resuscitate are based on the ethical principle of respect for patient autonomy, as the wishes of family members and physicians often do not match those of patients. In addition to the issue of autonomy, advanced discussions can help the medical and care team anticipate future problems and, thus, better plan patient care. Our opinion is that discussions regarding the resuscitation of critically ill patients should be performed for all patients within the first 24 to 48 hours after admission to the intensive care unit.

10.
JAMA ; 322(3): 216-228, 2019 07 16.
Artigo em Inglês | MEDLINE | ID: mdl-31310297

RESUMO

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain. Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium. Design, Setting and Participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018. Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation. Main Outcomes and Measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory). Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation. Conclusions and Relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium. Trial Registration: ClinicalTrials.gov Identifier: NCT02932358.


Assuntos
Delírio/prevenção & controle , Família/psicologia , Unidades de Terapia Intensiva/organização & administração , Visitas a Pacientes , Ansiedade , Brasil , Esgotamento Profissional , Cuidados Críticos/psicologia , Estudos Cross-Over , Depressão , Feminino , Educação em Saúde , Hospitalização , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
12.
Crit Care ; 23(1): 213, 2019 06 11.
Artigo em Inglês | MEDLINE | ID: mdl-31186070

RESUMO

BACKGROUND: As more patients are surviving intensive care, mental health concerns in survivors have become a research priority. Among these, post-traumatic stress disorder (PTSD) can have an important impact on the quality of life of critical care survivors. However, data on its burden are conflicting. Therefore, this systematic review and meta-analysis aimed to evaluate the prevalence of PTSD symptoms in adult critical care patients after intensive care unit (ICU) discharge. METHODS: We searched MEDLINE, EMBASE, LILACS, Web of Science, PsycNET, and Scopus databases from inception to September 2018. We included observational studies assessing the prevalence of PTSD symptoms in adult critical care survivors. Two reviewers independently screened studies and extracted data. Studies were meta-analyzed using a random-effects model to estimate PTSD symptom prevalence at different time points, also estimating confidence and prediction intervals. Subgroup and meta-regression analyses were performed to explore heterogeneity. Risk of bias was assessed using the Joanna Briggs Institute tool and the GRADE approach. RESULTS: Of 13,267 studies retrieved, 48 were included in this review. Overall prevalence of PTSD symptoms was 19.83% (95% confidence interval [CI], 16.72-23.13; I2 = 90%, low quality of evidence). Prevalence varied widely across studies, with a wide range of expected prevalence (from 3.70 to 43.73% in 95% of settings). Point prevalence estimates were 15.93% (95% CI, 11.15-21.35; I2 = 90%; 17 studies), 16.80% (95% CI, 13.74-20.09; I2 = 66%; 13 studies), 18.96% (95% CI, 14.28-24.12; I2 = 92%; 13 studies), and 20.21% (95% CI, 13.79-27.44; I2 = 58%; 7 studies) at 3, 6, 12, and > 12 months after discharge, respectively. CONCLUSION: PTSD symptoms may affect 1 in every 5 adult critical care survivors, with a high expected prevalence 12 months after discharge. ICU survivors should be screened for PTSD symptoms and cared for accordingly, given the potential negative impact of PTSD on quality of life. In addition, action should be taken to further explore the causal relationship between ICU stay and PTSD, as well as to propose early measures to prevent PTSD in this population. TRIAL REGISTRATION: PROSPERO, CRD42017075124 , Registered 6 December 2017.

13.
BMJ Open ; 9(6): e028570, 2019 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-31243035

RESUMO

INTRODUCTION: There is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest. METHODS AND ANALYSIS: The study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor. ETHICS AND DISSEMINATION: The institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: NCT03179020; Pre-results.

15.
J Crit Care ; 52: 115-125, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31035186

RESUMO

PURPOSE: The present systematic review and meta-analysis aimed to synthesize data on subject outcomes associated with post-ICU follow-up. MATERIALS AND METHODS: MEDLINE, PsycINFO, CINAHL, Cochrane CENTRAL, and EMBASE databases were searched according to pre-specified criteria (PROSPERO- CRD42017074734). Non-randomized and randomized studies assessing patient and family outcomes associated with post-ICU follow-up were included. RESULTS: Twenty-six studies were included. Sixteen (61%) were randomized trials; of these, 15 were meta-analyzed. Non-randomized studies reported benefits in survival, functional status, anxiety, depression, and posttraumatic stress disorder (PTSD) symptoms, and satisfaction. In randomized trials, post-ICU follow-up models focusing on physical therapy were associated with fewer depression symptoms (mean difference [MD], -1.21 (see Fig. 2); 95% confidence interval [CI], -2.31 to -0.11; I2 = 0%) and better mental health-related quality of life scores (standardized MD [SMD], 0.26; 95%CI, 0.02 to 0.51; I2 = 6%) in the short term. Post-ICU follow-up models focusing on psychological or medical management interventions were associated with fewer PTSD symptoms (SMD, -0.21; 95%CI, -0.37 to -0.05; I2 = 0%) in the medium term. CONCLUSIONS: Post-ICU follow-up may improve depression symptoms and mental health-related quality of life in the short term for models focusing on physical therapy and PTSD symptoms in the medium term for models focusing on psychological or medical management interventions.

16.
Rev. bras. ter. intensiva ; 30(4): 405-413, out.-dez. 2018. tab, graf
Artigo em Português | LILACS-Express | ID: biblio-977985

RESUMO

RESUMO Objetivo: Avaliar a prevalência de incapacidades físicas, cognitivas e psiquiátricas, fatores associados e sua relação com qualidade de vida em pacientes sobreviventes de internação em unidades de terapia intensiva brasileiras. Métodos: Um estudo de coorte prospectivo multicêntrico está sendo conduzido em dez unidades de terapia intensiva adulto clínico-cirúrgicas representativas das cinco regiões geopolíticas do Brasil. Pacientes com idade ≥ 18 anos que receberam alta das unidades de terapia intensiva participantes e permaneceram internados na unidade de terapia intensiva por 72 horas ou mais, nos casos de internação clínica ou cirúrgica de urgência, e por 120 horas ou mais, nos casos de internação cirúrgica eletiva, serão incluídos de forma consecutiva. Estes pacientes serão seguidos por 1 ano, por meio de entrevistas telefônicas estruturadas 3, 6 e 12 meses pós-alta da unidade de terapia intensiva. Dependência funcional, disfunção cognitiva, sintomas de ansiedade e depressão, sintomas de estresse pós-traumático, qualidade de vida relacionada à saúde, re-hospitalizações e mortalidade em longo prazo serão avaliados como desfechos. Discussão: O presente estudo tem o potencial de contribuir para o conhecimento a respeito da prevalência e dos fatores associados à síndrome pós-cuidados intensivos na população de pacientes adultos sobreviventes de internação em unidades de terapia intensiva brasileiras. Ademais, a associação entre síndrome pós-cuidados intensivos e qualidade de vida relacionada à saúde poderá ser estabelecida.


ABSTRACT Objective: To establish the prevalence of physical, cognitive and psychiatric disabilities, associated factors and their relationship with the qualities of life of intensive care survivors in Brazil. Methods: A prospective multicenter cohort study is currently being conducted at 10 adult medical-surgical intensive care units representative of the 5 Brazilian geopolitical regions. Patients aged ≥ 18 years who are discharged from the participating intensive care units and stay 72 hours or more in the intensive care unit for medical or emergency surgery admissions or 120 hours or more for elective surgery admissions are consecutively included. Patients are followed up for a period of one year by means of structured telephone interviews conducted at 3, 6 and 12 months after discharge from the intensive care unit. The outcomes are functional dependence, cognitive dysfunction, anxiety and depression symptoms, posttraumatic stress symptoms, health-related quality of life, rehospitalization and long-term mortality. Discussion: The present study has the potential to contribute to current knowledge of the prevalence and factors associated with postintensive care syndrome among adult intensive care survivors in Brazil. In addition, an association might be established between postintensive care syndrome and health-related quality of life.

18.
Trials ; 19(1): 636, 2018 Nov 19.
Artigo em Inglês | MEDLINE | ID: mdl-30454019

RESUMO

BACKGROUND: Most adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals. METHODS/DESIGN: The ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data. DISCUSSION: This a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02932358 . Registered on 11 October 2016.

20.
Respir Care ; 63(12): 1471-1477, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30018175

RESUMO

BACKGROUND: Few studies have evaluated the effects of mechanical insufflation-exsufflation (MI-E) in subjects on mechanical ventilation. Therefore, this study aimed to evaluate the effectiveness of MI-E on airway mucus clearance among mechanically ventilated ICU subjects. METHODS: A randomized, parallel-group, open-label trial was conducted between June and November 2017 in a single, mixed ICU. Adult ICU subjects receiving mechanical ventilation for > 24 h with stable ventilatory and hemodynamic status were randomized to receive either standard respiratory physiotherapy alone (control group) or respiratory physiotherapy by using an MI-E device (intervention group). The primary outcome was the weight of aspirated airway mucus after study interventions. Secondary outcomes included variation in static lung compliance (ΔCL), airway resistance (ΔRaw), work of breathing (ΔWOB) in relation to the pre-intervention period, and hemodynamic and ventilator complications during the procedures. RESULTS: There were 90 subjects in each group. The mean ± SD weight of the aspirated airway mucus was higher in the intervention group than in the control group (2.42 ± 2.32 g vs 1.35 ± 1.56 g, P < .001). The ΔCL values in the intervention group were higher than those in the control group (1.76 ± 4.90 mL/cm H2O vs -0.57 ± 4.85 mL/cm H2O, P = .001). The ΔRaw and ΔWOB values were similar between the groups. No hemodynamic or ventilatory complications were observed. CONCLUSIONS: Among the general ICU subjects receiving mechanical ventilation, use of an MI-E device during respiratory physiotherapy resulted in a larger amount of airway mucus clearance than respiratory physiotherapy alone. (ClinicalTrials.gov registration NCT03178565.).

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