NCT07571759

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2025

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 14, 2026

Last Update Submit

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

EXPERIMENTAL
Behavioral: intervention group

The control group

NO INTERVENTION

Interventions

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

The intervention group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations