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

Study Overview

• Status: Completed
• Conditions: Craniocerebral Tumors
• Intervention / Treatment: Behavioral: intervention group

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • The Affiliated Brain Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The intervention group	Behavioral: intervention group; The intervention group received a comprehensive PPRNS, including preoperative respiratory training, postoperative exercises, early mobilization, and multidisciplinary care.
No Intervention: The control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity (FVC)	Assessed via portable spirometry. Expressed in liters (L).	Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)
Recovery Metrics (Functional Recovery Indicators)	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	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	Intracranial hematoma Worsened cerebral edema Neurological deterioration Deep vein thrombosis (DVT) Surgical site infection	Within 14 days post-surgery
Postoperative Length of Hospital Stay	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	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)	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)	Measured at rest on room air. Expressed as percentage (%).	Preoperative, postoperative day 1, and postoperative day 3
Barthel Index Score	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	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)	Assessed via portable spirometry. Measured in liters (L).	Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)
Time to First Ambulation	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety / Adverse Events	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

Collaborators and Investigators

• Sponsor: The Affiliated Brain Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Actual): December 7, 2025
• Study Completion (Actual): December 16, 2025

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 30, 2026
• First Posted (Actual): May 6, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: No. 2026-KY030-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No