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Completed

NCT Number: NCT07571759

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

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Key information

Conditions

Craniocerebral Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Brain Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention Group

Behavioral

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

Primary outcomes

  1. Incidence of Postoperative Pulmonary Complications (PPCs)

    Time frame: 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

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)

    Assessed via portable spirometry. Expressed in liters (L).

  2. Recovery Metrics (Functional Recovery Indicators)

    Time frame: 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

  3. Postoperative Length of Hospital Stay

    Time frame: At hospital discharge, assessed through study completion (average of 14 days)

    Time from surgery date to hospital discharge meeting clinical criteria. Measured in days.

  4. Incidence of Other (Non-Pulmonary) Complications

    Time frame: Within 14 days post-surgery

    Intracranial hematoma

    Worsened cerebral edema

    Neurological deterioration

    Deep vein thrombosis (DVT)

    Surgical site infection

  5. Postoperative Length of Hospital Stay

    Time frame: 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.

  6. Patient Satisfaction with Nursing Care

    Time frame: 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.

  7. Peak Expiratory Flow (PEF)

    Time frame: Preoperative, postoperative day 1, and postoperative day 14 (or hospital discharge)

    Measured by a peak flow meter. Expressed in liters per minute (L/min).

  8. Peripheral Oxygen Saturation (SpO₂)

    Time frame: Preoperative, postoperative day 1, and postoperative day 3

    Measured at rest on room air. Expressed as percentage (%).

  9. Barthel Index Score

    Time frame: 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).

  10. 36-Item Short Form Health Survey (SF-36) Total Score

    Time frame: 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).

  11. Forced Vital Capacity (FVC)

    Time frame: Preoperative, postoperative day 1, and postoperative day 14 (or at hospital discharge)

    Assessed via portable spirometry. Measured in liters (L).

  12. Time to First Ambulation

    Time frame: 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.

  13. Time to First Effective Autonomous Cough

    Time frame: 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.

Other outcomes

  1. Safety / Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The Affiliated Brain Hospital of Nanjing Medical University

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.