- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04914065
Predictors of Prognosis in Patients With Critical Illness.
Recently, intensive care unit acquired weakness (ICUAW) has become a hotspot issue in the patients with critical illness. The symptoms of ICUAW, including sensory impairment and muscle atrophy, may lead to poor quality of life even though the patients discharged from the ICU for a long time. Therefore, an ounce of prevention is worth a pound of cure. At the same time, early evaluation is necessary to keep critically ill patients away from ICUAW. Medical Research Council (MRC) scale is the most common approach for diagnosis clinically. Regarding the interrater variation of MRC, handgrip strength (HGS) has been thought to be a simple and accurate alternative. However, HGS does not belong to antigravity or respiratory muscle which are the first to be affected by immobilization. It is still unknown whether HGS can represent the general muscle condition in ICU or not.
Additionally, previous studies have proved that patients with critical illness in the ICU would have better prognosis and less complications, if they undergo physical therapy as soon as possible. In addition to early ventilator weaning and reduced mortality rate, physical therapy could enhance quality of life (QoL) after patient discharges from hospital. However, early mobility in the ICU mainly emphasizes cardiopulmonary patients due to the traditional concept in Taiwan. Hence, the duration of mechanical ventilation in the critical patients will affect the timing to receive physical therapy, even impact the improvement of QoL.
Because of these reasons, this study will investigate the relationship between HGS and muscle mass among patients with critical illness and find the predictors of the short-term and long-term goals in the ICU, including ventilator weaning and QoL after hospital discharge.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This prospective and observational study will be divided into 2 parts: 1) The association between handgrip strength and muscle mass in intensive care unit patients. 2) Predictors of short-term and long-term goals in ICU.
Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours from admission to ICU. The outcome measures include HGS assessed by electronic hand dynamometer and muscle thickness of diaphragm and quadriceps detected by ultrasound.
The short-term goal is weaning ventilator, and the long-term goal is quality of life after discharge from hospital assessed through SF-36 Taiwan version. Patients in the surgery intensive care unit of Taoyuan General Hospital will be recruited and evaluated in 48 hours after ICU admission. The collected data contain muscle strength, muscle mass, physical function, respiratory function, and observation of delirium or not. The evaluations of muscle strength include 3 parts which are limbs(handgrip), respiratory muscle(Maximal Inspiratory Pressure), and general muscle strength(Medical Research Council scale); Secondly, the evaluations of muscle mass divide 2 parts which are limbs(muscle thickness of quadriceps) and respiratory muscle(muscle thickness of diaphragm); Thirdly, the evaluations of physical function are 2 ways which are FSS-ICU and 2 mins walk test after discharge from the ICU; Fourthly, the evaluations of respiratory function contain 3 measurements of FEV1, FVC, and FEV1/FVC; Finally, the evaluation of delirium is assessed by CAM-ICU.
The statistical analysis will use SPSS version 24. Pearson correlation test will be conducted to investigate the association between HGS and muscle thickness. Multiple regression will be used to investigate the predictors for weaning ventilator successfully and quality of life after hospital discharge.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Taoyuan, Taiwán, 330
- Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare, Taiwan
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients in the surgery intensive care unit will be recruited and evaluated in 48 hours from admission to ICU
Exclusion Criteria:
- Hemodynamic instability patients, e.g., patients with ECMO
- Patients refuse to participate this study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Part 1: Change of handgrip strength (HGS) from ICU admission to ICU discharge
Periodo de tiempo: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
|
Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
|
every day during the ICU stay until patients discharge from ICU assessed up to 14 days
|
Part 1: Change of diaphragm thickness from ICU admission to ICU discharge
Periodo de tiempo: every day during the ICU stay until patients discharge from ICU assessed up to 14 days
|
Muscle thickness of diaphragm and quadriceps detected by ultrasound(GE vivid S5)
|
every day during the ICU stay until patients discharge from ICU assessed up to 14 days
|
Part 2: Change of Handgrip strength (HGS)
Periodo de tiempo: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Change of Handgrip strength (HGS) assessed by electronic hand dynamometer(Electronic hand dynamometer, CAMRY, MODEL, EH101)
|
Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Part 2: Change of General muscle strength
Periodo de tiempo: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Change of General muscle strength- MRC scale
|
Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Part 2: Change of Muscle mass
Periodo de tiempo: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Muscle thickness of diaphragm and quadriceps detected by ultrasound (GE vivid S5)
|
Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Part 2: Respiratory muscle strength
Periodo de tiempo: the day that patient received weaning profile tests during ICU
|
Respiratory muscle strength- Maximal Inspiratory Pressure(MIP)
|
the day that patient received weaning profile tests during ICU
|
Part 2: Change of Physical function
Periodo de tiempo: Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Change of FSS-ICU
|
Baseline: admission to ICU in 48 hours. Progress: the day that patients received weaning profile test
|
Part 2: Physical function at ICU discharge
Periodo de tiempo: conducted at the day of ICU discharge
|
2 mins walk test
|
conducted at the day of ICU discharge
|
Part 2: Change of Delirium
Periodo de tiempo: conducted every day in the ICU
|
CAM-ICU
|
conducted every day in the ICU
|
Part 2: Respiratory function
Periodo de tiempo: conducted at the day of ICU discharge
|
FVC, FEV1, FEV1/ FVC assessed by ezOxygen (EZO-G001)
|
conducted at the day of ICU discharge
|
Part 2: Quality of life- SF-36(Taiwan version)
Periodo de tiempo: conducted by phone call at discharge for 6 months from ICU
|
SF-36(Taiwan version)
|
conducted by phone call at discharge for 6 months from ICU
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Huan-Jui Yeh, Department of Rehabilitation, Taoyuan General Hospital, Ministry of Health and Welfare
Publicaciones y enlaces útiles
Publicaciones Generales
- Fuke R, Hifumi T, Kondo Y, Hatakeyama J, Takei T, Yamakawa K, Inoue S, Nishida O. Early rehabilitation to prevent postintensive care syndrome in patients with critical illness: a systematic review and meta-analysis. BMJ Open. 2018 May 5;8(5):e019998. doi: 10.1136/bmjopen-2017-019998.
- Jolley SE, Bunnell AE, Hough CL. ICU-Acquired Weakness. Chest. 2016 Nov;150(5):1129-1140. doi: 10.1016/j.chest.2016.03.045. Epub 2016 Apr 7.
- Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.
- Thille AW, Boissier F, Muller M, Levrat A, Bourdin G, Rosselli S, Frat JP, Coudroy R, Vivier E. Role of ICU-acquired weakness on extubation outcome among patients at high risk of reintubation. Crit Care. 2020 Mar 12;24(1):86. doi: 10.1186/s13054-020-2807-9.
- Meyer-Friessem CH, Malewicz NM, Rath S, Ebel M, Kaisler M, Tegenthoff M, Schildhauer TA, Pogatzki-Zahn EM, Maier C, Zahn PK. Incidence, Time Course and Influence on Quality of Life of Intensive Care Unit-Acquired Weakness Symptoms in Long-Term Intensive Care Survivors. J Intensive Care Med. 2021 Nov;36(11):1313-1322. doi: 10.1177/0885066620949178. Epub 2020 Aug 17.
- Cottereau G, Dres M, Avenel A, Fichet J, Jacobs FM, Prat D, Hamzaoui O, Richard C, Antonello M, Sztrymf B. Handgrip Strength Predicts Difficult Weaning But Not Extubation Failure in Mechanically Ventilated Subjects. Respir Care. 2015 Aug;60(8):1097-104. doi: 10.4187/respcare.03604. Epub 2015 Mar 10.
- Kutchak FM, Rieder MM, Victorino JA, Meneguzzi C, Poersch K, Forgiarini LA Junior, Bianchin MM. Simple motor tasks independently predict extubation failure in critically ill neurological patients. J Bras Pneumol. 2017 May-Jun;43(3):183-189. doi: 10.1590/S1806-37562016000000155.
- Saiphoklang N, Tepwimonpetkun C. Interest of hand grip strength to predict outcome in mechanically ventilated patients. Heart Lung. 2020 Sep-Oct;49(5):637-640. doi: 10.1016/j.hrtlng.2020.03.019. Epub 2020 May 6.
- Braganca RD, Ravetti CG, Barreto L, Ataide TBLS, Carneiro RM, Teixeira AL, Nobre V. Use of handgrip dynamometry for diagnosis and prognosis assessment of intensive care unit acquired weakness: A prospective study. Heart Lung. 2019 Nov-Dec;48(6):532-537. doi: 10.1016/j.hrtlng.2019.07.001. Epub 2019 Jul 15.
- Sidiras G, Patsaki I, Karatzanos E, Dakoutrou M, Kouvarakos A, Mitsiou G, Routsi C, Stranjalis G, Nanas S, Gerovasili V. Long term follow-up of quality of life and functional ability in patients with ICU acquired Weakness - A post hoc analysis. J Crit Care. 2019 Oct;53:223-230. doi: 10.1016/j.jcrc.2019.06.022. Epub 2019 Jun 21.
- Vanhorebeek I, Latronico N, Van den Berghe G. ICU-acquired weakness. Intensive Care Med. 2020 Apr;46(4):637-653. doi: 10.1007/s00134-020-05944-4. Epub 2020 Feb 19.
- Bohannon RW, Wang YC, Gershon RC. Two-minute walk test performance by adults 18 to 85 years: normative values, reliability, and responsiveness. Arch Phys Med Rehabil. 2015 Mar;96(3):472-7. doi: 10.1016/j.apmr.2014.10.006. Epub 2014 Oct 25.
- Zein H, Baratloo A, Negida A, Safari S. Ventilator Weaning and Spontaneous Breathing Trials; an Educational Review. Emerg (Tehran). 2016 Spring;4(2):65-71.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TYGH108031
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Calidad de vida
-
Queens College, The City University of New YorkReclutamientoPublicación de artículos enviados al American Journal of Public HealthEstados Unidos
-
Yale-NUS CollegeTerminadoEl enfoque del estudio son las respuestas de los pacientes a un cuestionario de control de la obesidad administrado por SGH Life CenterSingapur
-
Children's Healthcare of AtlantaTerminadoNiños que se sometieron a un trasplante de corazón antes de los 18 años | Atención recibida en Children's Healthcare of AtlantaEstados Unidos
-
Yale-NUS CollegeTerminadoEl enfoque del estudio son las respuestas de los pacientes a un cuestionario de control de la obesidad administrado por SGH Life CenterSingapur