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Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors

Development and Preliminary Validation of a Perioperative Pulmonary Rehabilitation Nursing System for Patients With Craniocerebral Tumors

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07571759
Enrollment
165
Registered
2026-05-06
Start date
2025-02-05
Completion date
2025-12-16
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniocerebral Tumors

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

Interventions

BEHAVIORALintervention group

The intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care.

Sponsors

The Affiliated Brain Hospital of Nanjing Medical University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Pulmonary Complications (PPCs)Within 14 days post-surgeryDescription: 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

Secondary

MeasureTime frameDescription
Forced Vital Capacity (FVC)Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)Assessed via portable spirometry. Expressed in liters (L).
Recovery Metrics (Functional Recovery Indicators)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
Postoperative Length of Hospital StayAt hospital discharge, assessed through study completion (average of 14 days)Time from surgery date to hospital discharge meeting clinical criteria. Measured in days.
Incidence of Other (Non-Pulmonary) ComplicationsWithin 14 days post-surgeryIntracranial hematoma Worsened cerebral edema Neurological deterioration Deep vein thrombosis (DVT) Surgical site infection
Patient Satisfaction with Nursing CareAt 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.
Peak Expiratory Flow (PEF)Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)Measured by a peak flow meter. Expressed in liters per minute (L/min).
Peripheral Oxygen Saturation (SpO₂)Preoperative, postoperative day 1, and postoperative day 3Measured at rest on room air. Expressed as percentage (%).
Barthel Index ScoreAt 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).
36-Item Short Form Health Survey (SF-36) Total ScoreAt 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).
Time to First AmbulationFrom surgery end to first ambulation, assessed up to 14 days post-surgeryTime from surgery end to first standing or walking with or without assistance. Measured in hours.
Time to First Effective Autonomous CoughFrom surgery end to first effective cough, assessed up to 7 days post-surgeryTime from surgery end to first effective cough performed independently by the patient (able to clear secretions). Measured in hours.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026