Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery (positioning)
13 de agosto de 2015 actualizado por: Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital
Study of Impact of Three Body Positioning Strategies in the Drainage Fluids in the Immediate Postoperative Period in Patients After Coronary Artery Bypass Surgery
To investigate different strategies of body positioning associated to early corporal mobilization and verify the impact int the time and quantification of thoracic and mediastinal drainage, pulmonary complications and time of intensive care units in hospitals stay.
After first six hours post extubation in the first postoperative day and after evaluation and inclusion in the study, patients were randomized in three groups for receiving different strategies of body positioning associated to early mobilization with help of bed Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous Lateral Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT n=34).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Coronary artery bypass surgery can lead to pulmonary complications like pleural effusion and pneumonia.
These complications increase the length of stay and the immobility time.
The investigators aim was to assess the impact of early mobilization of fluids drainage of chest tubes and the incidence of pulmonary complications.
A prospective, randomized study included 101 patients divided in three groups.
In the Control Group (CG:n=33) the patients were seated in armchair in the first 48 hours postoperative time.
The Group (TRCL n=34) a Continuous Rotational Bed Therapy was instituted six hours post extubation in the first 24 hours and it comprised with by consecutive cycles of lateral rotation to the left and right side, and supine position with 30 seconds for pauses (using a Hill Rom Rotational Bed Device) witch stopped when need to perform routine measurements the hemodynamics measurements and clinical controls by nursing crew.The group ( ORT n=33) following the sequential steps T1: sitting in the bed for 2 hours, T2: sitting on the bed with their feet on the floor for 2 minutes and T3: the patients stoos up and walked on the spot for 2 minutes.
Hemodynamics and oxygenation measurement before and after each intervention.
Tipo de estudio
Intervencionista
Inscripción (Actual)
101
Fase
- Fase 1
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- first postoperative day of cardiovascular surgery 6 hours after extubation
- EFVE> 35%
- writen inform consent
Exclusion Criteria:
- neurological alteration
- hemodynamics instability with PAM < 60 mmHg
- blood
- pneumothorax or broncopleural
- arritymias
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control Group
six hours after extubation receiving breathing exercises.
After 48 hour postoperative time, sitting on armchair and keeping the erect position and walking in the same place.
|
|
|
Comparador activo: Bed Rotation Group
six hours after extubation receiving breathing exercises and submitted the continuous rotational bed therapy in the first postoperative day until 48 hours.
|
Patients received continuous lateral rotation by a mechanical device (Hill Rom Bed Rotation), consecutive cycles of to left and right side, plus supine position during 30 seconds for pause, in the first postoperative day until 48 hours.
Additional breathing exercises.
|
|
Comparador activo: Orthostatic Group
six hours after extubation receiving breathing exercises and changing the body position following the sequence: sitting on the bed, sitting on the bed with the feet on the floor , standing and walking in the same place, in the first postoperative day until 48 hours.
|
Patients were seated on the bed 6 hours post extubation for two hours.
After, sitting in the bed with their feet on the floor for two minutes; standing up and walking in the place for two minutes, in the first 24 hours and 48 hours postoperative.
Additional breathing exercises.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
volume of drainage fluids
Periodo de tiempo: 48 hours
|
measure of volume of drainage fluids (mililiter) pre and post intervention until extract the mediastinal and/or thoracic tube
|
48 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
score of pulmonary complications
Periodo de tiempo: 7 days
|
incidence of postoperative pulmonary complications, was scored by a blinded independent investigator on an ordinal scale of 1 to 4
|
7 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Filomena G Gallas, PHD, University of Sao Paulo
- Silla de estudio: Ludhmila A Hajjar, PHD, University of Sao Paulo Medical School
- Director de estudio: Maria Ignêz Z Feltrim, PHD, Heart Intsitute (InCor) Hospital das Clinicas - FMUSP
- Silla de estudio: Camila CM Buzzeto, PT, Heart Institute (InCor) Hospital das Clinicas - FMUSP
- Silla de estudio: Vera RM Coimbra, PT, Heart Institute (InCor) Hospital das Clinicas _ FMUSP
- Silla de estudio: Adriano RB Rodrigues, Nursing, Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
- Silla de estudio: Cristiane D Gonçalves, PT, Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
- Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL. Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA. 2006 Oct 18;296(15):1851-7. doi: 10.1001/jama.296.15.1851.
- Kirkeby-Garstad I, Stenseth R, Sellevold OF. Post-operative myocardial dysfunction does not affect the physiological response to early mobilization after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2005 Oct;49(9):1241-7. doi: 10.1111/j.1399-6576.2005.00854.x.
- Goldhill DR, Imhoff M, McLean B, Waldmann C. Rotational bed therapy to prevent and treat respiratory complications: a review and meta-analysis. Am J Crit Care. 2007 Jan;16(1):50-61; quiz 62.
- Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009 May;18(3):212-21. doi: 10.4037/ajcc2009598. Epub 2009 Feb 20.
- Kirschenbaum L, Azzi E, Sfeir T, Tietjen P, Astiz M. Effect of continuous lateral rotational therapy on the prevalence of ventilator-associated pneumonia in patients requiring long-term ventilatory care. Crit Care Med. 2002 Sep;30(9):1983-6. doi: 10.1097/00003246-200209000-00006.
- Sonnenblick M, Melzer E, Rosin AJ. Body positional effect on gas exchange in unilateral pleural effusion. Chest. 1983 May;83(5):784-6. doi: 10.1378/chest.83.5.784.
- Sachdev G, Napolitano LM. Postoperative pulmonary complications: pneumonia and acute respiratory failure. Surg Clin North Am. 2012 Apr;92(2):321-44, ix. doi: 10.1016/j.suc.2012.01.013.
- Mirmohammad-Sadeghi M, Etesampour A, Gharipour M, Shariat Z, Nilforoush P, Saeidi M, Mackie M, Sadeghi FM. Early chest tube removal after coronary artery bypass graft surgery. N Am J Med Sci. 2009 Dec;1(7):333-7. doi: 10.4297/najms.2009.7333.
- Ahrens T, Kollef M, Stewart J, Shannon W. Effect of kinetic therapy on pulmonary complications. Am J Crit Care. 2004 Sep;13(5):376-83.
- Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
- Kirkeby-Garstad I, Sellevold OFM, Stenseth R, Skogvoll E, Karevold A. Marked mixed venous desaturation during early mobilization after aortic valve surgery. Anesth Analg. 2004 Feb;98(2):311-317. doi: 10.1213/01.ANE.0000096194.10459.7E.
- Kroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992 May;152(5):967-71.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2012
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
20 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
13 de agosto de 2015
Publicado por primera vez (Estimar)
17 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de agosto de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
13 de agosto de 2015
Última verificación
1 de agosto de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 141372
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