Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors
Title of Study:
A New Nursing System to Help Lung Recovery After Brain Tumor Surgery
Why was this study done? After surgery for a brain tumor (craniocerebral tumor), some patients develop lung problems like pneumonia or collapsed lung areas (atelectasis). These problems can slow down recovery, keep patients in the hospital longer, and make them feel worse. Doctors and nurses wanted to find a better way to protect the lungs and help patients breathe easier after surgery.
What did the researchers want to find out? They wanted to see if a special, step-by-step nursing system for lung recovery-called the Perioperative Pulmonary Rehabilitation Nursing System (PPRNS) -could reduce lung problems after brain tumor surgery and help patients get back on their feet faster.
What was done in the study?
Who: 165 patients having brain tumor surgery at one hospital.
How: Patients were put into two groups by chance (like flipping a coin):
Control group (81 patients): Received regular, standard care after surgery.
Intervention group (84 patients): Received the new PPRNS care. This included:
Before surgery: Breathing exercises, learning to cough effectively, and nutrition advice.
During surgery: Lung-protective methods by the anesthesia team.
After surgery: Deep breathing exercises, sitting up and moving early, help clearing mucus from the lungs, and close monitoring.
What was measured: The main thing measured was how many patients developed lung problems (like pneumonia) within 14 days after surgery. They also checked lung function, how fast patients recovered (walking, eating, removing tubes), length of hospital stay, and patient satisfaction.
What were the main results?
Fewer lung problems: Only 4.8% of patients in the new care group developed lung complications, compared to 13.6% in the regular care group. This means the new system cut lung problems by more than half.
Better breathing: Patients in the new care group had stronger lung function tests (FVC, PEF) and higher oxygen levels after surgery.
Faster recovery: They got off breathing tubes earlier, started walking sooner, cou
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- The Affiliated Brain Hospital of Nanjing Medical University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 18 to 75 years, inclusive
Preoperative diagnosis of intracranial tumor confirmed by imaging and/or pathology per WHO Classification of Tumours of the Central Nervous System (5th edition), with planned craniotomy for tumor resection (initial or recurrent surgery)
Preoperative assessment confirms ability to cooperate with pulmonary rehabilitation training (adequate consciousness, cognition, and communication for short-term training)
Voluntary participation with written informed consent
Exclusion Criteria:
- Pre-existing severe chronic obstructive pulmonary disease (COPD GOLD stages 3-4)
Pre-existing severe interstitial lung disease
Requirement for long-term oxygen therapy
Pneumonia or respiratory failure requiring mechanical ventilation within one month prior to surgery
Severe cardiac dysfunction (New York Heart Association class III-IV)
Other major organ insufficiency
Severe impairment of consciousness
Inability to follow commands
Language barriers
Life expectancy less than 30 days
Concurrent participation in other interventional studies that could confound pulmonary function outcomes
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: O grupo de intervenção
|
The intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care.
|
|
Sem intervenção: O grupo de controle
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Postoperative Pulmonary Complications (PPCs)
Prazo: Within 14 days post-surgery
|
Description: The occurrence of respiratory system-related complications, including but not limited to: Pneumonia (diagnosed based on clinical symptoms, laboratory findings, and radiographic evidence: fever, purulent sputum, pulmonary rales, new infiltrates on chest X-ray or CT) Atelectasis (confirmed radiographically) Severe hypoxemia requiring intervention Airway spasm Aspiration |
Within 14 days post-surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Forced Vital Capacity (FVC)
Prazo: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
|
Assessed via portable spirometry.
Expressed in liters (L).
|
Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
|
|
Recovery Metrics (Functional Recovery Indicators)
Prazo: From surgery end until achievement (measured in hours or days)
|
Surgery end through extubation, assessed up to 72 hours Surgery end through first effective cough, assessed up to 7 days Surgery end through first standing/walking, assessed up to 14 days Surgery end through catheter removal, assessed up to 14 days Surgery end through first oral intake, assessed up to 14 days
|
From surgery end until achievement (measured in hours or days)
|
|
Postoperative Length of Hospital Stay
Prazo: At hospital discharge, assessed through study completion (average of 14 days)
|
Time from surgery date to hospital discharge meeting clinical criteria.
Measured in days.
|
At hospital discharge, assessed through study completion (average of 14 days)
|
|
Incidence of Other (Non-Pulmonary) Complications
Prazo: Within 14 days post-surgery
|
Intracranial hematoma Worsened cerebral edema Neurological deterioration Deep vein thrombosis (DVT) Surgical site infection |
Within 14 days post-surgery
|
|
Postoperative Length of Hospital Stay
Prazo: At hospital discharge, assessed through study completion (average of 14 days post-surgery)
|
Time from surgery date to hospital discharge meeting clinical criteria.
Measured in days.
|
At hospital discharge, assessed through study completion (average of 14 days post-surgery)
|
|
Patient Satisfaction with Nursing Care
Prazo: At hospital discharge (average of 14 days post-surgery)
|
Patient satisfaction with perioperative nursing care measured using a 100-point satisfaction scale (0 to 100 points).
Higher scores indicate greater satisfaction (better outcome).
Note: This is a non-validated satisfaction scale designed for this study.
|
At hospital discharge (average of 14 days post-surgery)
|
|
Peak Expiratory Flow (PEF)
Prazo: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
|
Measured by a peak flow meter.
Expressed in liters per minute (L/min).
|
Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
|
|
Peripheral Oxygen Saturation (SpO₂)
Prazo: Preoperative, postoperative day 1, and postoperative day 3
|
Measured at rest on room air.
Expressed as percentage (%).
|
Preoperative, postoperative day 1, and postoperative day 3
|
|
Barthel Index Score
Prazo: At hospital discharge (average of 14 days post-surgery)
|
Barthel Index assesses functional independence in activities of daily living.
Total score ranges from 0 to 100.
Higher scores indicate better functional independence (better outcome).
|
At hospital discharge (average of 14 days post-surgery)
|
|
36-Item Short Form Health Survey (SF-36) Total Score
Prazo: At hospital discharge (average of 14 days post-surgery)
|
SF-36 assesses health-related quality of life.
Total score ranges from 0 to 100.
Higher scores indicate better quality of life (better outcome).
|
At hospital discharge (average of 14 days post-surgery)
|
|
Forced Vital Capacity (FVC)
Prazo: Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
|
Assessed via portable spirometry.
Measured in liters (L).
|
Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
|
|
Time to First Ambulation
Prazo: From surgery end to first ambulation, assessed up to 14 days post-surgery
|
Time from surgery end to first standing or walking with or without assistance.
Measured in hours.
|
From surgery end to first ambulation, assessed up to 14 days post-surgery
|
|
Time to First Effective Autonomous Cough
Prazo: From surgery end to first effective cough, assessed up to 7 days post-surgery
|
Time from surgery end to first effective cough performed independently by the patient (able to clear secretions).
Measured in hours.
|
From surgery end to first effective cough, assessed up to 7 days post-surgery
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Safety / Adverse Events
Prazo: Within 14 days post-surgery
|
Any unplanned respiratory support/reintubation related to the respiratory system Any adverse events related to the intervention (e.g., falls during early mobilization, injury from respiratory exercises) - not explicitly reported but implied under non-pu |
Within 14 days post-surgery
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- No. 2026-KY030-01
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .