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The Effect of Care Protocol on the Outcomes of Patients With Lung Surgery

23 de julio de 2021 actualizado por: Dilara Soydan, Mersin University

Improving Pulmonary Function The Effect of Care Protocol on the Outcomes of Patients With Thoracotomy

This randomized controlled trial evaluates the effect of the care protocol, which consists of independent nursing interventions, which play an important role in accelerating the recovery process of the patient, such as the patient's position, mobilization, use of spirometry, and providing shoulder exercises after thoracotomy. The hypothesis of this research is; the care protocol applied to the patients after thoracotomy has an effect on the patients' pulmonary function tests (FVC, FEV1, FEV1/FVC) and on the mobilization of the patients, the development of complications, the time of chest tube removal and the discharge

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

Methods: In the study, 80 patients were randomly assigned to the study and control groups. Nursing interventions will be applied to the patients included in the study group (n=40), starting from the 0th day (the first day spent in the intensive care unit) after the thoracotomy in line with the prepared care protocol application steps until discharge. maintenance protocol; It will consist of position of the patient, mobilization, use of spirometer and shoulder exercises. The primary outcome of the research is the effect of the maintenance protocol used in the improvement of respiratory function on respiratory function tests. The secondary outcome of the research is to determine the effect of the care protocol on mobilization, complication development status, chest tube removal and discharge time in patients. The results are obtained by recording PFT values on the 1st, 5th and discharge days before and after thoracotomy. Postoperative (0.,1.,2.,3.,4.,5.) days and discharge day; mobilization, complication development status, chest tube removal time and discharge date will be recorded on the Patient Results Form.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

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

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Accepting to participate in the research,
  • 18 years and older,
  • Conscious, oriented and cooperative,
  • Able to speak and understand Turkish,
  • Does not have any psychiatric disease,
  • Elective thoracotomy performed,
  • Chest tube inserted,
  • Patients who were followed up in the intensive care unit on the first day after surgery and admitted to the clinic the next day
  • Patients without a history of metastatic disease

Exclusion Criteria:

  • Those who do not accepted to participate in the research,
  • Under 18 years of age,
  • Unconscious, without orientation and cooperation,
  • Who cannot speak or understand Turkish,
  • Having a psychiatric problem,
  • Non thoracotomy
  • Non chest tube,
  • Metastatic disease,
  • Emergency thoracotomy applied,
  • Patients staying in the intensive care unit for more than one day.

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: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control group
In the control group (n=40), interventions for the position, mobilization and spirometry of the patient are applied to all patients in the clinic where the study was conducted. However, these applications are not made in accordance with a certain order and protocol. Shoulder exercises are not routinely taught to patients. In the study, no additional application will be made to the control group other than the routine treatment and care practice of the clinic.
Experimental: Intervention
Care protocol will be applied to the study group (n=40), starting from the first day spent in the intensive care unit.Care protocol consists of patient's position, mobilization, use of spirometer and shoulder exercises. The bed head of the patient will be raised 30°-45° in line with the application steps. In the study, the patient's in-bed and out-of-bed mobilization will be provided by considering the mobilization application steps, and the patient will be asked to stay out of bed for two hours on the 0 th day after surgery. The patient will be asked to stay out of bed for six hours from the first postoperative day until discharge. After the thoracotomy, the conditions that the doctor considers as complications will be recorded.The time of chest tube removal and the day of discharge will be recorded. In the study, the use of spirometry and shoulder exercises will be carried out by taking into account the implementation steps of the care protocol.
Otro: Care protocol

Before starting the application, the investigator (DS) will fill out the Introductory Characteristics Form of all patients, the Pre-thoracotomy Pulmonary Function Test (PFT) section of the Patient Results Form. The PFT section will be re-evaluated on the 1st, 5th day and on the day of discharge after thoracotomy.

Nursing interventions will be applied to the study group (n=40), starting from the 0th day (the first day spent in the intensive care unit) after the thoracotomy in line with the prepared care protocol application steps until discharge. Care protocol consists of patient's position, mobilization, use of spirometer and shoulder exercises.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pulmonary function test values evaluated using the care protocol
Periodo de tiempo: Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks
Pulmonary function tests. Pulmonary function tests will be measured with a portable pulmonary function tester. In the evaluation, FVC (%), FEV1 (%) and FEV1/FVC (%) parameters will be used
Change from before implementation preoperative and postoperative (1.,5.) days and an average of 2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mobilization evaluated using the care protocol
Periodo de tiempo: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
In the study, the patient's in-bed and out-of-bed mobilization will be provided by considering the mobilization application steps, and the patient will be asked to stay out of bed for two hours on the 0 th day after surgery. In the clinic, the patient will be mobilized in line with the mobilization application steps. The patient will be asked to stay out of bed for six hours from the first postoperative day until discharge. The steps taken will be recorded with the pedometer
Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
Prevention of complications evaluated using the care protocol
Periodo de tiempo: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
After the thoracotomy, the conditions that the doctor considers as complications (atelectasis, pneumonia, air leak, bronchospasm, subcutaneous emphysema, atrial fibrillation) will be recorded and daily evaluation will be made.
Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
Chest tube removal evaluated using the care protocol
Periodo de tiempo: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
The time of chest tube removal and the day will be recorded in the Patient Results Form
Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
Discharge time evaluated using the care protocol
Periodo de tiempo: Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks
The time of discharge will be recorded in the Patient Results Form
Change from before implementation and postoperative (0.,1.,2.,3.,4.,5.) days and an average of 2 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Mersin University

Investigadores

  • Director de estudio: GÜLAY ALTUN UĞRAŞ, Doctorate, Researcher

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 (Anticipado)

28 de agosto de 2021

Finalización primaria (Anticipado)

28 de agosto de 2022

Finalización del estudio (Anticipado)

30 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

7 de julio de 2021

Primero enviado que cumplió con los criterios de control de calidad

23 de julio de 2021

Publicado por primera vez (Actual)

27 de julio de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de julio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

23 de julio de 2021

Última verificación

1 de julio de 2021

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • MersinUniversityNursingFaculty

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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