Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors
1 other identifier
interventional
165
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2025
CompletedFirst Submitted
Initial submission to the registry
April 14, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedMay 6, 2026
April 1, 2026
10 months
April 14, 2026
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Postoperative Pulmonary Complications (PPCs)
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
Secondary Outcomes (13)
Forced Vital Capacity (FVC)
Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
Recovery Metrics (Functional Recovery Indicators)
From surgery end until achievement (measured in hours or days)
Postoperative Length of Hospital Stay
At hospital discharge, assessed through study completion (average of 14 days)
Incidence of Other (Non-Pulmonary) Complications
Within 14 days post-surgery
Postoperative Length of Hospital Stay
At hospital discharge, assessed through study completion (average of 14 days post-surgery)
- +8 more secondary outcomes
Other Outcomes (1)
Safety / Adverse Events
Within 14 days post-surgery
Study Arms (2)
The intervention group
EXPERIMENTALThe control group
NO INTERVENTIONInterventions
The intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Brain Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 14, 2026
First Posted
May 6, 2026
Study Start
February 5, 2025
Primary Completion
December 7, 2025
Study Completion
December 16, 2025
Last Updated
May 6, 2026
Record last verified: 2026-04