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
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国、210029
- The Affiliated Brain Hospital of Nanjing Medical University
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：介入グループ
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The intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care.
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介入なし：コントロールグループ
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of Postoperative Pulmonary Complications (PPCs)
時間枠：Within 14 days post-surgery
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Forced Vital Capacity (FVC)
時間枠：Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
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Assessed via portable spirometry.
Expressed in liters (L).
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Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
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Recovery Metrics (Functional Recovery Indicators)
時間枠：From surgery end until achievement (measured in hours or days)
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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
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From surgery end until achievement (measured in hours or days)
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Postoperative Length of Hospital Stay
時間枠：At hospital discharge, assessed through study completion (average of 14 days)
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Time from surgery date to hospital discharge meeting clinical criteria.
Measured in days.
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At hospital discharge, assessed through study completion (average of 14 days)
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Incidence of Other (Non-Pulmonary) Complications
時間枠：Within 14 days post-surgery
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Intracranial hematoma Worsened cerebral edema Neurological deterioration Deep vein thrombosis (DVT) Surgical site infection |
Within 14 days post-surgery
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Postoperative Length of Hospital Stay
時間枠：At hospital discharge, assessed through study completion (average of 14 days post-surgery)
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Time from surgery date to hospital discharge meeting clinical criteria.
Measured in days.
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At hospital discharge, assessed through study completion (average of 14 days post-surgery)
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Patient Satisfaction with Nursing Care
時間枠：At hospital discharge (average of 14 days post-surgery)
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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.
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At hospital discharge (average of 14 days post-surgery)
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Peak Expiratory Flow (PEF)
時間枠：Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
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Measured by a peak flow meter.
Expressed in liters per minute (L/min).
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Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
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Peripheral Oxygen Saturation (SpO₂)
時間枠：Preoperative, postoperative day 1, and postoperative day 3
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Measured at rest on room air.
Expressed as percentage (%).
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Preoperative, postoperative day 1, and postoperative day 3
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Barthel Index Score
時間枠：At hospital discharge (average of 14 days post-surgery)
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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).
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At hospital discharge (average of 14 days post-surgery)
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36-Item Short Form Health Survey (SF-36) Total Score
時間枠：At hospital discharge (average of 14 days post-surgery)
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SF-36 assesses health-related quality of life.
Total score ranges from 0 to 100.
Higher scores indicate better quality of life (better outcome).
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At hospital discharge (average of 14 days post-surgery)
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Forced Vital Capacity (FVC)
時間枠：Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
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Assessed via portable spirometry.
Measured in liters (L).
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Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
|
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Time to First Ambulation
時間枠：From surgery end to first ambulation, assessed up to 14 days post-surgery
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Time from surgery end to first standing or walking with or without assistance.
Measured in hours.
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From surgery end to first ambulation, assessed up to 14 days post-surgery
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Time to First Effective Autonomous Cough
時間枠：From surgery end to first effective cough, assessed up to 7 days post-surgery
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Time from surgery end to first effective cough performed independently by the patient (able to clear secretions).
Measured in hours.
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From surgery end to first effective cough, assessed up to 7 days post-surgery
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Safety / Adverse Events
時間枠：Within 14 days post-surgery
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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
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- No. 2026-KY030-01
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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