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Effect of Preoperative Chest Physiotherapy on Lung Functions Among Open Heart Surgery Patients

10 de diciembre de 2020 actualizado por: University of Pecs

The Effect of Preoperative Chest Physiotherapy on Oxygenation and Lung Functions Among Open Heart Surgery Patients

Postoperative respiratory complications in patients who had chest-opening heart surgery are considered one of the serious factors threatening their life. However, these potential complications could be minimized using proper preoperative chest physiotherapy. This study was designed to assess the potential effects of using preoperative chest physiotherapy on oxygenation and lung functions among open heart surgery patients during postoperative period.

Descripción general del estudio

Descripción detallada

The research was lasted four months in outpatient clinic, cardiothoracic surgical department and intensive care unit at University of Pécs, Clinical Centre, Heart Institute, Hungary . A convenient sample of 100 patients were divided into two groups: group 1 and 2. Group 1 (G1) included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation, and group 2 (G2) included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home. Preoperative and postoperative chest physiotherapy was performed in G1, and only postoperative one made in G2. Potential effects of preoperative chest physiotherapy were studied in both groups with respect to oxygen saturation, pulmonary complications and length of hospital staying. O2 saturation,O2 supplementation, forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) were all measured in a day before (zero day) surgery as well as the first seven days of postoperative period.

Results: Measures of oxygen level and lung functions were significantly (P<0.05) changed in studied groups. The mean values of O2 saturation and supplementation measured in almost seven days of postoperative period were significantly (p<0.05) higher among G1 compared to the values of G2. The same trend was also correct for the mean values of FVC and FEV1.

Conclusions: The results concluded that, the performance of preoperative chest physiotherapy before open heart surgery is recommended, as it might result in the decrease of complications of heart surgery, improvement of respiratory functions and length of staying at hospital.

Tipo de estudio

Intervencionista

Inscripción (Actual)

100

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.

Ubicaciones de estudio

    • Pecs
      • Pécs, Pecs, Hungría, H-7621
        • Heart Institute,Medical School, University of Pécs

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

-

Exclusion Criteria:

  • Under 18 years old; (2) a history of musculoskeletal disorders; (3) patients who had suffered strokes; (4) and psychological disorders.

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Group 1

G1 included patients undergoing planned surgery who performed chest physiotherapy at home in two weeks period before the surgical operation pre and postoperative chest physiotherapy was performed in G1.

The chest physiotherapy included the following steps

  1. Snipping through the nose several times, then breathe out through the mouth
  2. Taking a deep breath through the nose, hold the air in, push it down in the stomach, than back to the chest, and in the end breath out through the mouth
  3. Put both hands on the shoulders. Lift the elbows to the sides and take a deep breath through the nose, then lower them, breathe out through the mouth. This procedure was done for the other side as well.
  4. Put both hands on your hips. Lift your right arm to the side, turn backwards with it and take a deep breath through the nose, then turn back, put your hand back to the hip and breathe out through the mouth.This procedure was done for the other side as well

The patients were approached to partake in the investigation after they got full clarifications about the point of study. They were allocated into two groups and reassurance was achieved about the absence of any side effects.Furthermore, the examination was approved by the ethical committee.

Effects of preoperative chest physiotherapy were compared between two groups, by measuring the lung functions, oxygen saturation, pulmonary complications and length of hospital staying. Lung functions were completed by utilizing spirometry parameters, oxygen saturation was measured by pulse oximeter and pulmonary complications were diagnosed by specialist doctors.

Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days.
Comparador activo: Group 2

G2 included patients who patients undergoing planned surgery but did not perform preoperative chest physiotherapy at home.only postoperative chest physiotherapy made in G2.

The patient was seen on the first day after surgery in the intensive care unit and was asked if he had performed breathing exercises at home before surgery and then re-evaluation of both groups with respect to respiratory functions and oxygen saturation values from the first day until the seventh after surgery. Also, a daily chest physical therapy program was introduced in accordance with the hospital's policy until the patient's discharge.

Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy mentioned above but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days.

The exercises were repeated 10 times and performed 3-4 times per day.

Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the "lectures" of postoperative days.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in oxygen saturation
Periodo de tiempo: in a day before (zero day) surgery as well as the first seven days of postoperative period.
Sao2
in a day before (zero day) surgery as well as the first seven days of postoperative period.
Change in pulmonary functions
Periodo de tiempo: At the first seven days of postoperative period
FVC and FEV1
At the first seven days of postoperative period

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pulmonary complications
Periodo de tiempo: At the first seven days of postoperative period.
pneumonia, atelectasis, phrenic nerve stimulation, ventilator
At the first seven days of postoperative period.
length of hospital staying
Periodo de tiempo: The minimum stay for the patient is 7 days
How many days did the patient stay in the hospital?
The minimum stay for the patient is 7 days

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Director de estudio: VERZAR 7- ZSOFIA, Doctor, University of Pecs

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.

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 (Actual)

1 de abril de 2018

Finalización primaria (Actual)

30 de septiembre de 2019

Finalización del estudio (Actual)

1 de octubre de 2020

Fechas de registro del estudio

Enviado por primera vez

9 de diciembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

10 de diciembre de 2020

Publicado por primera vez (Actual)

11 de diciembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de diciembre de 2020

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

10 de diciembre de 2020

Última verificación

1 de diciembre de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 4114.316-474/kk15/2011

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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