Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

23 de julho de 2021 atualizado 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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Antecipado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Pulmonary function test values evaluated using the care protocol
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mobilization evaluated using the care protocol
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Mersin University

Investigadores

  • Diretor de estudo: GÜLAY ALTUN UĞRAŞ, Doctorate, Researcher

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Antecipado)

28 de agosto de 2021

Conclusão Primária (Antecipado)

28 de agosto de 2022

Conclusão do estudo (Antecipado)

30 de dezembro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

7 de julho de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de julho de 2021

Primeira postagem (Real)

27 de julho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de julho de 2021

Última verificação

1 de julho de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • MersinUniversityNursingFaculty

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever