RESUMEN
OBJECTIVE: To study the airflow, transmission, and clearance of aerosols in the clinical spaces of a hospital ward that had been used to care for patients with coronavirus disease 2019 (COVID-19) and to examine the impact of portable air cleaners on aerosol clearance. DESIGN: Observational study. SETTING: A single ward of a tertiary-care public hospital in Melbourne, Australia. INTERVENTION: Glycerin-based aerosol was used as a surrogate for respiratory aerosols. The transmission of aerosols from a single patient room into corridors and a nurses' station in the ward was measured. The rate of clearance of aerosols was measured over time from the patient room, nurses' station and ward corridors with and without air cleaners [ie, portable high-efficiency particulate air (HEPA) filters]. RESULTS: Aerosols rapidly travelled from the patient room into other parts of the ward. Air cleaners were effective in increasing the clearance of aerosols from the air in clinical spaces and reducing their spread to other areas. With 2 small domestic air cleaners in a single patient room of a hospital ward, 99% of aerosols could be cleared within 5.5 minutes. CONCLUSIONS: Air cleaners may be useful in clinical spaces to help reduce the risk of acquisition of respiratory viruses that are transmitted via aerosols. They are easy to deploy and are likely to be cost-effective in a variety of healthcare settings.
Asunto(s)
Filtros de Aire , COVID-19 , Aire Acondicionado , COVID-19/prevención & control , Hospitales , Humanos , Aerosoles y Gotitas RespiratoriasRESUMEN
OBJECT: This study was conducted to compare the quality of life (QOL) in patients with neurogenic intermittent claudication (NIC) secondary to lumbar spinal stenosis (LSS). Using the 36-Item Short Form (SF-36) questionnaire, the authors compared the results obtained in patients treated with the X STOP Interspinous Process Decompression (IPD) System with those obtained in patients who underwent nonoperative therapies. METHODS: Patients with LSS were enrolled in a prospective 2-year multicenter study and randomized either to the X STOP or nonoperative group. The SF-36 survey was used to assess the QOL before treatment and at 6 weeks, 6 months, 1 year, and 2 years posttreatment. An analysis of variance was used to compare individual pre- and posttreatment mean SF-36 domain scores between the two groups and within each treatment group. At all posttreatment time points, the authors observed the following: (1) mean domain scores in X STOP-treated patients were significantly greater than those in patients treated nonoperatively, with the exception of the mean General Health (GH), Role Emotional, and Mental Component Summary scores at 2 years; and (2) mean posttreatment domain scores documented in X STOP-treated patients were significantly greater than mean pretreatment scores, with the exception of mean GH scores at 6, 12, and 24 months. CONCLUSIONS: The results of this study demonstrate that the X STOP device is significantly more effective than nonoperative therapy in improving the QOL in patients with LSS. The results are comparable with those reported in other studies involving traditional decompressive techniques for LSS and suggest that the X STOP implant can provide an effective treatment compared with nonoperative and conventional surgical therapies.
Asunto(s)
Descompresión Quirúrgica/instrumentación , Prótesis e Implantes , Implantación de Prótesis/métodos , Calidad de Vida , Estenosis Espinal/cirugía , Anciano , Descompresión Quirúrgica/métodos , Femenino , Humanos , Claudicación Intermitente/etiología , Laminectomía , Vértebras Lumbares/cirugía , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Recuperación de la Función , Estenosis Espinal/complicaciones , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
STUDY DESIGN: Multicenter, prospective single-arm study in patients diagnosed with neurogenic intermittent claudication because of lumbar spinal stenosis. OBJECTIVE: To collect data from 2 different primary patient populations, new participants meeting entry criteria [Continued Access Program (CAP)], or subjects who had been randomly assigned to nonsurgical management in the pivotal Investigational Device Exemption study and failed to respond upon study completion [Crossover Study (COS)]. SUMMARY OF BACKGROUND DATA: The X-STOP interspinous spacer is a minimally invasive treatment option for neurogenic intermittent claudication shown to improve pain, physical functioning, and/or overall quality of life. METHODS: Fifty-five subjects were enrolled, 42 in CAP and 13 in COS. Zurich Claudication Questionnaire (ZCQ) success rates were obtained based on the number of subjects achieving a threshold level of success. Mean SF-36 domain scores were compared with baseline using repeated measures analysis of variance. RESULTS: Eighty percent of subjects completed the study. At 2 years, 26/43 subjects (60.5%) achieved clinically significant improvement in the Symptom Severity domain, 25/43 (58.1%) achieved clinically significant improvement in the Physical Function domain, and 31/44 (70.5%) achieved clinically significant improvement in the Patient Satisfaction domain of the ZCQ. Statistically significant improvement in mean scores was obtained in all physical domains of the SF-36 (with the exception of General Health) at 24 months. Mean improvement in ZCQ and SF-36 scores was not as pronounced in the COS cohort compared with the CAP cohort. The most frequently reported device-related or treatment-related adverse event was stenosis pain reported by 3 subjects. CONCLUSIONS: Overall data are consistent with the randomized pivotal Investigational Device Exemption trial. On the basis of the COS cohort which was subject to several additional years of failed conservative treatment, overall success rates do not improve as greatly in patients with long-standing lumbar spinal stenosis symptoms.
Asunto(s)
Claudicación Intermitente , Vértebras Lumbares/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Implantación de Prótesis , Estenosis Espinal/complicaciones , Resultado del Tratamiento , Anciano , Anciano de 80 o más Años , Estudios Cruzados , Equipos y Suministros , Femenino , Humanos , Claudicación Intermitente/diagnóstico , Claudicación Intermitente/etiología , Claudicación Intermitente/cirugía , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Encuestas y Cuestionarios , Estados UnidosAsunto(s)
Vértebras Lumbares/cirugía , Prótesis e Implantes/economía , Implantación de Prótesis/economía , Implantación de Prótesis/instrumentación , Estenosis Espinal/economía , Estenosis Espinal/cirugía , Anciano , Análisis Costo-Beneficio/economía , Análisis Costo-Beneficio/métodos , Femenino , Humanos , Fijadores Internos , Masculino , Persona de Mediana Edad , Implantación de Prótesis/métodosRESUMEN
STUDY DESIGN: A randomized, controlled, prospective multicenter trial comparing the outcomes of neurogenic intermittent claudication (NIC) patients treated with the interspinous process decompression system (X STOP) with patients treated nonoperatively. OBJECTIVE: To determine the safety and efficacy of the X STOP interspinous implant. SUMMARY OF BACKGROUND DATA: Patients suffering from NIC secondary to lumbar spinal stenosis have been limited to a choice between nonoperative therapies and decompressive surgical procedures, with or without fusion. The X STOP was developed to provide an alternative therapeutic treatment. METHODS.: 191 patients were treated, 100 in the X STOP group and 91 in the control group. The primary outcomes measure was the Zurich Claudication Questionnaire, a patient-completed, validated instrument for NIC. RESULTS: At every follow-up visit, X STOP patients had significantly better outcomes in each domain of the Zurich Claudication Questionnaire. At 2 years, the X STOP patients improved by 45.4% over the mean baseline Symptom Severity score compared with 7.4% in the control group; the mean improvement in the Physical Function domain was 44.3% in the X STOP group and -0.4% in the control group. In the X STOP group, 73.1% patients were satisfied with their treatment compared with 35.9% of control patients. CONCLUSIONS: The X STOP provides a conservative yet effective treatment for patients suffering from lumbar spinal stenosis. In the continuum of treatment options, the X STOP offers an attractive alternative to both conservative care and decompressive surgery.