Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial.

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.

Effectiveness and Safety of an Extended ICU Visitation Model for Delirium Prevention: A Before and After Study.

OBJECTIVES: To evaluate the effect of an extended visitation model compared with a restricted visitation model on the occurrence of delirium among ICU patients. DESIGN: Prospective single-center before and after study. SETTING: Thirty-one-bed medical-surgical ICU. PATIENTS: All patients greater than or equal to 18 years old with expected length of stay greater than or equal to 24 hours consecutively admitted to the ICU from May 2015 to November 2015. INTERVENTIONS: Change of visitation policy from a restricted visitation model (4.5 hr/d) to an extended visitation model (12 hr/d). MEASUREMENTS AND MAIN RESULTS: Two hundred eighty-six patients were enrolled (141 restricted visitation model, 145 extended visitation model). The primary outcome was the cumulative incidence of delirium, assessed bid using the confusion assessment method for the ICU. Predefined secondary outcomes included duration of delirium/coma; any ICU-acquired infection; ICU-acquired bloodstream infection, pneumonia, and urinary tract infection; all-cause ICU mortality; and length of ICU stay. The median duration of visits increased from 133 minutes (interquartile range, 97.7-162.0) in restricted visitation model to 245 minutes (interquartile range, 175.0-272.0) in extended visitation model (p < 0.001). Fourteen patients (9.6%) developed delirium in extended visitation model compared with 29 (20.5%) in restricted visitation model (adjusted relative risk, 0.50; 95% CI, 0.26-0.95). In comparison with restricted visitation model patients, extended visitation model patients had shorter length of delirium/coma (1.5 d [interquartile range, 1.0-3.0] vs 3.0 d [interquartile range, 2.5-5.0]; p = 0.03) and ICU stay (3.0 d [interquartile range, 2.0-4.0] vs 4.0 d [interquartile range, 2.0-6.0]; p = 0.04). The rate of ICU-acquired infections and all-cause ICU mortality did not differ significantly between the two study groups. CONCLUSIONS: In this medical-surgical ICU, an extended visitation model was associated with reduced occurrence of delirium and shorter length of delirium/coma and ICU stay.

The 6-Minute Walk Test predicts long-term physical improvement among intensive care unit survivors: a prospective cohort study. / O Teste de Caminhada de 6 Minutos prevê a melhora física em longo prazo de sobreviventes à unidade de terapia intensiva: um estudo de coorte prospectiva.

OBJECTIVE: To evaluate the ability of the 6-Minute Walk Test to predict long-term physical functional status improvement among intensive care unit survivors. METHODS: Thirty-two intensive care unit survivors were prospectively evaluated from February 2017 to August 2018 in a post-intensive care unit outpatient clinic in Brazil. Individuals with intensive care unit stays > 72 hours (emergency admissions) or > 120 hours (elective admissions) attending the post-intensive care unit clinic four months after intensive care unit discharge were consecutively enrolled. The association between the 6-Minute Walk Test distance at baseline and physical functional status was assessed over 8 months using the Barthel Index. RESULTS: The mean 6-Minute Walk Test distance was significantly lower in intensive care unit survivors than in the general population (405m versus 557m; p < 0.001). Age (ß = -4.0; p < 0.001) and muscle weakness (ß = -99.7; p = 0.02) were associated with the 6-Minute Walk Test distance. A 6-Minute Walk Test distance was associated with improvement in physical functional status over the 8-month follow-up (odds ratio for each 10m of 1.07; 95%CI 1.01 - 1.16; p = 0.03). The area under the Receiver Operating Characteristic curve for the 6-Minute Walk Test prediction of physical functional status improvement was 0.72 (95%CI 0.53 - 0.88). CONCLUSION: The 6-Minute Walk Test performed 4 months after intensive care unit discharge predicted long-term physical functional status among intensive care unit survivors with moderate accuracy.

OBJETIVO: Avaliar a capacidade do Teste de Caminhada de 6 Minutos para predizer a melhora do estado funcional físico em longo prazo de pacientes sobreviventes à unidade de terapia intensiva. MÉTODOS: Foram avaliados, de forma prospectiva, entre fevereiro de 2017 e agosto de 2018, em um ambulatório pós-unidade de terapia intensiva, 32 sobreviventes à unidade de terapia intensiva. Foram inscritos consecutivamente os pacientes com permanência na unidade de terapia intensiva acima de 72 horas (para admissões emergenciais) ou acima de 120 horas (para admissões eletivas) que compareceram ao ambulatório pós-unidade de terapia intensiva 4 meses após receberem alta da unidade de terapia intensiva. A associação entre a distância percorrida no Teste de Caminhada de 6 Minutos realizado na avaliação inicial e a evolução do estado funcional físico foi avaliada durante 8 meses, com utilização do Índice de Barthel. RESULTADOS: A distância média percorrida no Teste de Caminhada de 6 Minutos foi significantemente mais baixa nos sobreviventes à unidade de terapia intensiva do que na população geral (405m versus 557m; p < 0,001). A idade (ß = -4,0; p < 0,001) e a fraqueza muscular (ß = -99,7; p = 0,02) se associaram com a distância percorrida no Teste de Caminhada de 6 Minutos. A distância percorrida no Teste de Caminhada de 6 Minutos se associou com melhora do estado funcional físico no período de 8 meses de acompanhamento desses pacientes (razão de chance para cada 10m: 1,07; IC95% 1,01 - 1,16; p = 0,03). A área sob a curva Característica de Operação do Receptor para predição da melhora funcional física pelo Teste de Caminhada de 6 Minutos foi de 0,72 (IC95% 0,53 - 0,88). CONCLUSÃO: O Teste de Caminhada de 6 Minutos, realizado 4 meses após a alta da unidade de terapia intensiva, predisse com precisão moderada a melhora do estado funcional físico de sobreviventes à unidade de terapia intensiva.

Central venous saturation is a predictor of reintubation in difficult-to-wean patients.

OBJECTIVE: To evaluate the predictive value of central venous saturation to detect extubation failure in difficult-to-wean patients. DESIGN: Cohort, multicentric, clinical study. SETTING: Three medical-surgical intensive care units. PATIENTS: All difficult-to-wean patients (defined as failure to tolerate the first 2-hr T-tube trial), mechanically ventilated for >48 hrs, were extubated after undergoing a two-step weaning protocol (measurements of predictors followed by a T-tube trial). Extubation failure was defined as the need of reintubation within 48 hrs. INTERVENTIONS: The weaning protocol evaluated hemodynamic and ventilation parameters, and arterial and venous gases during mechanical ventilation (immediately before T-tube trial), and at the 30th min of spontaneous breathing trial. MEASUREMENTS AND MAIN RESULTS: Seventy-three patients were enrolled in the study over a 6-mo period. Reintubation rate was 42.5%. Analysis by logistic regression revealed that central venous saturation was the only variable able to discriminate outcome of extubation. Reduction of central venous saturation by >4.5% was an independent predictor of reintubation, with odds ratio of 49.4 (95% confidence interval 12.1-201.5), a sensitivity of 88%, and a specificity of 95%. Reduction of central venous saturation during spontaneous breathing trial was associated with extubation failure and could reflect the increase of respiratory muscles oxygen consumption. CONCLUSIONS: Central venous saturation was an early and independent predictor of extubation failure and may be a valuable accurate parameter to be included in weaning protocols of difficult-to-wean patients.

Mortality of Adult Critically Ill Subjects With Cancer.

BACKGROUND: Cancer patients may require intensive care support for postoperative care, complications associated with underlying malignancy, or toxicities related to cancer therapy. The higher mortality rates found in this population than in the population of ICU patients without cancer may be attributable to confounding due to a higher prevalence of multiple organic dysfunctions at ICU admission in patients with malignancy; however, data regarding this hypothesis are scarce. Accordingly, we performed the present study to compare the crude and propensity score-matched mortality rates between adult subjects with and without cancer admitted to a mixed medical-surgical ICU. METHODS: We conducted a retrospective analysis of a comprehensive longitudinal ICU database in a tertiary referral hospital in Southern Brazil. All adult subjects who were admitted to the ICU from January 2008 to December 2014 were evaluated. Crude and propensity score-matched all-cause 30-d mortality rates of critically ill subjects with cancer were compared with those of critically ill subjects without cancer. RESULTS: A total of 4,221 subjects were evaluated. The survival analysis revealed that the crude mortality rate was higher among subjects with cancer than among subjects without cancer (18.7% vs 10.2%, P < .001). However, after matching by propensity score, the 30-d mortality rates of subjects with and without cancer were similar (18.5% vs 15.2%, P = .17). CONCLUSIONS: The present study failed to show an association between malignancy and all-cause 30-d mortality rate in adult subjects admitted to a mixed medical-surgical ICU. The propensity score-matched analysis showed no evidence of excessive mortality due to cancer diagnosis.

Mechanical ventilation weaning protocol improves medical adherence and results.

INTRODUCTION: Implementation of a weaning protocol is related to better patient prognosis. However, new approaches may take several years to become the standard of care in daily practice. We conducted a prospective cohort study to investigate the effectiveness of a multifaceted strategy to implement a protocol to wean patients from mechanical ventilation (MV) and to evaluate the weaning success rate as well as practitioner adherence to the protocol. METHODS: We investigated all consecutive MV-dependent subjects admitted to a medical-surgical intensive care unit (ICU) for >24h over 7years. The multifaceted strategy consisted of continuing education of attending physicians and ICU staff and regular feedback regarding patient outcomes. The study was conducted in three phases: protocol development, protocol and multifaceted strategy implementation, and protocol monitoring. Data regarding weaning outcomes and physician adherence to the weaning protocol were collected during all phases. RESULTS: We enrolled 2469 subjects over 7years, with 1,943 subjects (78.7%) experiencing weaning success. Physician adherence to the protocol increased during the years of protocol and multifaceted strategy implementation (from 38% to 86%, p<0.01) and decreased in the protocol monitoring phase (from 73.9% to 50.0%, p<0.01). However, during the study years, the weaning success of all subjects increased (from 73.1% to 85.4%, p<0.001). When the weaning protocol was evaluated step-by-step, we found high adherence for noninvasive ventilation use (95%) and weaning predictor measurement (91%) and lower adherence for control of fluid balance (57%) and daily interruption of sedation (24%). Weaning success was higher in patients who had undergone the weaning protocol compared to those who had undergone weaning based in clinical practice (85.6% vs. 67.7%, p<0.001). CONCLUSIONS: A multifaceted strategy consisting of continuing education and regular feedback can increase physician adherence to a weaning protocol for mechanical ventilation.

O Teste de Caminhada de 6 Minutos prevê a melhora física em longo prazo de sobreviventes à unidade de terapia intensiva: um estudo de coorte prospectiva / The 6-Minute Walk Test predicts long-term physical improvement among intensive care unit survivors: a prospective cohort study

RESUMO Objetivo: Avaliar a capacidade do Teste de Caminhada de 6 Minutos para predizer a melhora do estado funcional físico em longo prazo de pacientes sobreviventes à unidade de terapia intensiva. Métodos: Foram avaliados, de forma prospectiva, entre fevereiro de 2017 e agosto de 2018, em um ambulatório pós-unidade de terapia intensiva, 32 sobreviventes à unidade de terapia intensiva. Foram inscritos consecutivamente os pacientes com permanência na unidade de terapia intensiva acima de 72 horas (para admissões emergenciais) ou acima de 120 horas (para admissões eletivas) que compareceram ao ambulatório pós-unidade de terapia intensiva 4 meses após receberem alta da unidade de terapia intensiva. A associação entre a distância percorrida no Teste de Caminhada de 6 Minutos realizado na avaliação inicial e a evolução do estado funcional físico foi avaliada durante 8 meses, com utilização do Índice de Barthel. Resultados: A distância média percorrida no Teste de Caminhada de 6 Minutos foi significantemente mais baixa nos sobreviventes à unidade de terapia intensiva do que na população geral (405m versus 557m; p < 0,001). A idade (β = -4,0; p < 0,001) e a fraqueza muscular (β = -99,7; p = 0,02) se associaram com a distância percorrida no Teste de Caminhada de 6 Minutos. A distância percorrida no Teste de Caminhada de 6 Minutos se associou com melhora do estado funcional físico no período de 8 meses de acompanhamento desses pacientes (razão de chance para cada 10m: 1,07; IC95% 1,01 - 1,16; p = 0,03). A área sob a curva Característica de Operação do Receptor para predição da melhora funcional física pelo Teste de Caminhada de 6 Minutos foi de 0,72 (IC95% 0,53 - 0,88). Conclusão: O Teste de Caminhada de 6 Minutos, realizado 4 meses após a alta da unidade de terapia intensiva, predisse com precisão moderada a melhora do estado funcional físico de sobreviventes à unidade de terapia intensiva.

ABSTRACT Objective: To evaluate the ability of the 6-Minute Walk Test to predict long-term physical functional status improvement among intensive care unit survivors. Methods: Thirty-two intensive care unit survivors were prospectively evaluated from February 2017 to August 2018 in a post-intensive care unit outpatient clinic in Brazil. Individuals with intensive care unit stays > 72 hours (emergency admissions) or > 120 hours (elective admissions) attending the post-intensive care unit clinic four months after intensive care unit discharge were consecutively enrolled. The association between the 6-Minute Walk Test distance at baseline and physical functional status was assessed over 8 months using the Barthel Index. Results: The mean 6-Minute Walk Test distance was significantly lower in intensive care unit survivors than in the general population (405m versus 557m; p < 0.001). Age (β = -4.0; p < 0.001) and muscle weakness (β = -99.7; p = 0.02) were associated with the 6-Minute Walk Test distance. A 6-Minute Walk Test distance was associated with improvement in physical functional status over the 8-month follow-up (odds ratio for each 10m of 1.07; 95%CI 1.01 - 1.16; p = 0.03). The area under the Receiver Operating Characteristic curve for the 6-Minute Walk Test prediction of physical functional status improvement was 0.72 (95%CI 0.53 - 0.88). Conclusion: The 6-Minute Walk Test performed 4 months after intensive care unit discharge predicted long-term physical functional status among intensive care unit survivors with moderate accuracy.

Nebulization during spontaneous breathing, CPAP, and bi-level positive-pressure ventilation: a randomized analysis of pulmonary radioaerosol deposition.

BACKGROUND: There have been few reports of factors affecting aerosol delivery during noninvasive ventilation (NIV). Nebulization is a standard practice, and our objective was to determine the effect of spontaneous breathing (SB) and NIV mode on lung technetium-99m ((99m)Tc) deposition in subjects with normal lungs. METHODS: Thirteen health care volunteers were submitted to a randomized radioaerosol nebulization with (99m)Tc during SB, CPAP (10 cm H2O), and bi-level positive-pressure ventilation (bi-level; inspiratory-expiratory pressures of 15/5 cm H2O). NIV was performed via a ventilator (VPAP II ST-A, ResMed, Sydney, Australia). The radioaerosol deposition was evaluated by pulmonary scintigraphy after 10 min of inhalation. Regions of interest (ROIs) were outlined on the left lung (LL), right lung (RL), and trachea (TRQ). The average number of counts/pixel in each ROI was determined, and the ratio of lung and trachea was calculated. RESULTS: The three techniques showed comparable lung deposition. Analysis of radioaerosol deposition in the lungs showed a mean count at RL of 108.7 ± 40 with CPAP, 111.5 ± 15 with bi-level, and 196.6 ± 167 with SB. At LL, the values were 92.7 ± 15 with CPAP, 98.4 ± 14 with bi-level, and 225.0 ± 293 with SB. There was no difference between the means of radioaerosol deposition in RL, LL, or TRQ, as well as the lung calculated ratio (LCR = [RL + LL]/TRQ), which was similar in comparing ventilatory strategies. CONCLUSIONS: Based on our data, there is an equivalent deposition of inhaled substances in individuals with healthy lungs when SB, CPAP, and bi-level are compared.

Impact of a mechanical ventilation weaning protocol on the extubation failure rate in difficult-to-wean patients.

OBJECTIVE: To determine whether the predictive accuracy of clinical judgment alone can be improved by supplementing it with an objective weaning protocol as a decision support tool. METHODS: This was a multicenter prospective cohort study carried out at three medical/surgical ICUs. The study involved all consecutive difficult-to-wean ICU patients (failure in the first spontaneous breathing trial [SBT]), on mechanical ventilation (MV) for more than 48 h, admitted between January of 2002 and December of 2005. The patients in the protocol group (PG) were extubated after a T-piece weaning trial and were compared with patients who were otherwise extubated (non-protocol group, NPG). The primary outcome measure was reintubation within 48 h after extubation. RESULTS: We included 731 patients-533 (72.9%) and 198 (27.1%) in the PG and NPG, respectively. The overall reintubation rate was 17.9%. The extubation success rates in the PG and NPG were 86.7% and 69.6%, respectively (p < 0.001). There were no significant differences between the groups in terms of age, gender, severity score, or pre-inclusion time on MV. However, COPD was more common in the NPG than in the PG (44.4% vs. 17.6%; p < 0.001), whereas sepsis and being a post-operative patient were more common in the PG (23.8% vs. 11.6% and 42.4% vs. 26.4%, respectively; p < 0.001 for both). The time on MV after the failure in the first SBT was higher in the PG than in the NPG (9 ± 5 days vs. 7 ± 2 days; p < 0.001). CONCLUSIONS: In this sample of difficult-to-wean patients, the use of a weaning protocol improved the decision-making process, decreasing the possibility of extubation failure.

Impacto de um protocolo de desmame de ventilação mecânica na taxa de falha de extubação em pacientes de difícil desmame / Impact of a mechanical ventilation weaning protocol on the extubation failure rate in difficult-to-wean patients

OBJETIVO: Determinar se a acurácia preditiva do julgamento clínico isolado pode ser melhorada com o uso suplementar de um protocolo de desmame objetivo como ferramenta de suporte para a tomada de decisão. MÉTODOS: Estudo prospectivo multicêntrico de coorte realizado em três UTIs clínicas/cirúrgicas. Foram incluídos no estudo todos os pacientes de difícil desmame (falha no primeiro teste de ventilação espontânea [TVE]), sob ventilação mecânica (VM) por mais de 48 h, admitidos em uma das UTIs entre janeiro de 2002 e dezembro de 2005. Os pacientes do grupo protocolo (GP) foram extubados após teste de tubo T de acordo com um protocolo de desmame e comparados com o grupo de pacientes extubados sem o uso do protocolo (GNP). O desfecho primário foi a taxa de reintubação em até 48 h após a extubação. RESULTADOS: Foram incluídos 731 pacientes - 533 (72,9%) no GP e 198 (27,1%) no GNP. A taxa global de reintubação foi de 17,9%. As taxas de sucesso da extubação no GP e no GNP foram 86,7% e 69,6%, respectivamente (p < 0,001). Não houve diferenças significativas entre os grupos quanto a idade, gênero, escore de gravidade e tempo de VM antes da inclusão. Entretanto, DPOC foi mais frequente no GNP que no GP (44,4% vs. 17,6%; p < 0,001), ao passo que pacientes sépticos e em pós-operatório foram mais comuns no GP (23,8% vs. 11,6% e 42,4% vs. 26,4%, respectivamente; p < 0,001 para ambos). O tempo de VM após a falha no primeiro TVE foi maior no GP que no GNP (9 ± 5 dias vs. 7 ± 2 dias; p < 0,001). CONCLUSÕES: Nesta amostra de pacientes de difícil desmame, o uso de um protocolo de desmame melhorou o processo decisório, reduzindo a possibilidade de falha na extubação.

OBJECTIVE: To determine whether the predictive accuracy of clinical judgment alone can be improved by supplementing it with an objective weaning protocol as a decision support tool. METHODS: This was a multicenter prospective cohort study carried out at three medical/surgical ICUs. The study involved all consecutive difficult-to-wean ICU patients (failure in the first spontaneous breathing trial [SBT]), on mechanical ventilation (MV) for more than 48 h, admitted between January of 2002 and December of 2005. The patients in the protocol group (PG) were extubated after a T-piece weaning trial and were compared with patients who were otherwise extubated (non-protocol group, NPG). The primary outcome measure was reintubation within 48 h after extubation. RESULTS: We included 731 patients-533 (72.9%) and 198 (27.1%) in the PG and NPG, respectively. The overall reintubation rate was 17.9%. The extubation success rates in the PG and NPG were 86.7% and 69.6%, respectively (p < 0.001). There were no significant differences between the groups in terms of age, gender, severity score, or pre-inclusion time on MV. However, COPD was more common in the NPG than in the PG (44.4% vs. 17.6%; p < 0.001), whereas sepsis and being a post-operative patient were more common in the PG (23.8% vs. 11.6% and 42.4% vs. 26.4%, respectively; p < 0.001 for both). The time on MV after the failure in the first SBT was higher in the PG than in the NPG (9 ± 5 days vs. 7 ± 2 days; p < 0.001). CONCLUSIONS: In this sample of difficult-to-wean patients, the use of a weaning protocol improved the decision-making process, decreasing the possibility of extubation failure.